meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
51
Latest Decision
1991-04-12

Clearances · page 121 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910233 LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST Laser Photonics, Inc. GEX Class II 1991-04-12
K910104 ANTI-FOG DISPOSABLE IV INDUCTION COVER Central Plastic, Inc. EYF Class I 1991-04-12
K905060 ELECTRODE EXTENDER Megadyne Medical Products, Inc. JOS Class II 1991-04-12
K910114 OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE Xintec Corporation GEX Class II 1991-04-09
K910051 SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65 Sharplan Lasers, Inc. GEX Class II 1991-04-08
K905624 PROBE SURGEON'S GLOVES- STERILE Glove India Pvt. , Ltd. KGO Class I 1991-04-08
K904421 CMS ONCOPROBE (TM) Cryomedical Sciences, Inc. GEH Class II 1991-04-08
K904420 DISPOSABLE FIBER OPTIC DELIVERY SYSTEM Fiber Delivery Concepts, Inc. GEX Class II 1991-04-08
K910137 PLP LAPAROSCOPIC CHOLECYSTECTOMY SET Precision Laser Products, Inc. GEX Class II 1991-04-08
K910461 OSTEONICS(R) MID-SHAFT CEMENT SPACER Osteonics Corp. JDK Class II 1991-04-08
K905459 SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM Angiosystems, Inc. LRO Class II 1991-04-05
K910036 SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES Surgical Technologies, Inc. GAA Class I 1991-04-04
K910783 SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M Smith & Nephew Equipment Group BWN Class I 1991-04-02
K910975 TEKDYNE MICRO RETRACTOR Tekdyne GAD Class I 1991-04-01
K905688 CUTINOVA HYDRO Beiersdorf, Inc. KOZ Class I 1991-04-01
K910897 PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X 3M Medical Products Group GDW Class II 1991-04-01
K911180 CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS Northgate Technologies, Inc. HTD Class I 1991-03-29
K905545 ULTRASOUND TRANSMISSION GEL Arbo Medical, Inc. JOT Class II 1991-03-29
K911159 PALPATION PROBE Northgate Technologies, Inc. GEN Class I 1991-03-29
K910726 LIGHT-TOUCH AND SURGI LIGHT FIBERS Lifestream Int'L, Inc. GEX Class II 1991-03-29
K910711 AMPRO SURGEON'S GLOVES American Pro Latex, Inc. KGO Class I 1991-03-29
K911247 YOURS TRULY ASYMMETRICAL BREAST FORM Jobst Institute, Inc. KCZ Class I 1991-03-29
K911158 MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM Northgate Technologies, Inc. LRW Class I 1991-03-29
K910655 COMBINED MALAR IMPLANT Implantech Associates, Inc. LZK Class II 1991-03-28
K910366 MEGA GENERAL PURPOSE INSTRUMENT KIT Megadyne Medical Products, Inc. KDD Class I 1991-03-28
K905708 TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM Trimedyne, Inc. GEX Class II 1991-03-28
K910914 SURGICAL TISSUE POUCH Cook Urological, Inc. KGY Class I 1991-03-28
K910365 WOUND CLOSURE KIT Megadyne Medical Products, Inc. LRO Class II 1991-03-28
K910369 INCISION AND DRAINAGE KIT Megadyne Medical Products, Inc. KDD Class I 1991-03-28
K910524 SURGICAL CLIPPER Baxter Healthcare Corp LWK Class I 1991-03-28
K910361 SUTURE REMOVAL KIT Megadyne Medical Products, Inc. MCZ Class I 1991-03-27
K910071 PORTA GAS COMPRESSED GAS CYLINDER CART Sen Tech Medical Corp. GET Class I 1991-03-22
K904930 SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH Directed Energy, Inc. GEX Class II 1991-03-21
K910468 STERILE DISPOSABLE DRAPE(S) E.M. Adams FZI Class II 1991-03-21
K905614 JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS Baxter Healthcare Corp GBX Class I 1991-03-20
K910110 TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK 3M Company FXX Class II 1991-03-20
K910271 VACPAC PORTABLE ASPIRATION SYSTEM Jedmed Instrument Co. BTA Class II 1991-03-20
K910383 HPI SENSI-SHIELD GLOVE KIT Hpi, Inc. KGO Class I 1991-03-20
K910084 SURGICAL DRAPE Biocor Medical, Inc. KKX Class II 1991-03-19
K910117 REDDICK IRRIGATION/ASPIRATION SYSTEM Ideal Medical, Inc. GAA Class I 1991-03-19
K905654 ELECTROSURGICAL UNIT WITH ACCESSORIES Aspen Labs GEI Class II 1991-03-18
K910368 MEGA LACERATION KIT Megadyne Medical Products, Inc. LRO Class II 1991-03-18
K905605 FORCE 10, 20, 30, AND 40 Valleylab, Inc. GEI Class II 1991-03-14
K905482 BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE Pfizer Hospital Products Group, Inc. GAM Class II 1991-03-14
K902449 STERILE SURGEON'S GLOVES Unigloves , Ltd. KGO Class I 1991-03-12
K910586 AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* United States Surgical, A Division of Tyco Healthc GDT Class I 1991-03-07
K904869 ELLIPSE PUNCH Kramer Const LRY Class I 1991-03-06
K905816 ORTHOVISION TABLE American Sterilizer Co. JEB Class I 1991-03-06
K905519 MONTROSE DRESSING APPLICATORS Olemunda Pty , Ltd. NAD Class I 1991-03-06
K905865 ANTI-FOR SURGICAL FACE MASK Anago, Inc. FXX Class II 1991-03-06
K904265 INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER Inamed Development Co. FZW Class I 1991-03-06
K910328 KEY COMFORT GRIPS Key Surgical, Inc. FSM Class I 1991-03-06
K904881 DISPOSABLE YANKAUER SUCTION TUBE Pilling Medical S.A. GEA Class I 1991-03-06
K905135 LAPAROTOMY SPONGES American Healthcare Corp. GDY Class I 1991-03-06
K905766 DRAINAGE TUBE RESTRAINT/WOUND COVER M. Imonti and Associates Inc., GBX Class I 1991-03-06
K903838 OPTILASE (TM) MODEL 900 ARGON Trimedyne, Inc. GEX Class II 1991-03-05
K905511 CODMAN NEUROLASE LASER SYSTEM/MODIFICATION I.L. Med, Inc. GEX Class II 1991-03-05
K910135 THE UNIVERSAL CEMENT PLUG(TM) Biotron , Ltd. LZN Class II 1991-03-05
K910182 3M BRAND EAR LOOP FACE MASK, 2000F 3M Company FXX Class II 1991-03-04
K905424 KTP DISC KIT Laserscope GEX Class II 1991-03-04
K905749 SURGICAL FACE MASK Anago, Inc. FXX Class II 1991-03-04
K910079 DISPOSABLE INTRODUCER SHEATH Applied Vascular Devices, Inc. KDC Class I 1991-02-27
K905529 VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE Valleylab, Inc. GEI Class II 1991-02-21
K905564 PREP AND OPERATING STAND Mcconnell Orthopedic FWZ Class I 1991-02-21
K905565 LATERAL BUTTRESS SUPPORT Mcconnell Orthopedic FWZ Class I 1991-02-21
K905006 SURGILASE SL 150 SURGICAL LASER SYSTEM Surgilase, Inc. GEX Class II 1991-02-21
K905004 BIO-GUARD O.R. SCRUB PREP TRAY Network Medical Systems, Inc. LRO Class II 1991-02-21
K904957 STERILE AND NON-STERILE TEXTILE PACKS Surgical Pack Services, Inc. KKX Class II 1991-02-21
K905209 SURGICAL MASK Lancaster County Blind Assoc. FXX Class II 1991-02-21
K910334 ELECTROCAUTERY PROBE Wiltek Medical, Inc. GEI Class II 1991-02-21
K910184 PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES Precision Laser Products, Inc. GEI Class II 1991-02-21
K904266 AUTODERM SCANNER CONTROL CONSOLE Charles I. Rose & Co., Inc. GEX Class II 1991-02-19
K905682 RICHARD-ALLAN CLAMP COVERS Richard-Allan Medical FSM Class I 1991-02-19
K905701 RICHARD-ALLAN SHEET CLIP Richard-Allan Medical KKX Class II 1991-02-19
K910457 ZARA EXTENDED CHIN IMPLANT Byron Medical FWP Class II 1991-02-19
K904700 ENDOCOAGULATOR KRS568(TM) LASER Hgm Medical Laser Systems, Inc. GEX Class II 1991-02-19
K910512 ACCUFLATE Instrumed, Inc. KCY Class I 1991-02-19
K910456 ZARA CHIN IMPLANT Byron Medical FWP Class II 1991-02-19
K903131 LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM Lasermatic, Inc. GEX Class II 1991-02-19
K910357 SOM 6V Jedmed Instrument Co. FSO Class I 1991-02-19
K910458 ZARA SOFT TIP CHIN IMPLANT Byron Medical FWP Class II 1991-02-19
K910495 QUALTEX SURGICAL DRAPE Deroyal Industries, Inc. KKX Class II 1991-02-19
K905315 ULTRACISION HARMONIC SCALPEL Ultracision, Inc. GEI Class II 1991-02-15
K904418 ULTRASOUND COUPLING GEL Geno Laboratories JOT Class II 1991-02-11
K905466 STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE Angiosystems, Inc. KKX Class II 1991-02-11
K905285 IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES Internacional Farmaceutica, S.A. DE C.V. GAS Class II 1991-02-11
K905286 IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES Internacional Farmaceutica, S.A. DE C.V. GAR Class II 1991-02-11
K905287 IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES Internacional Farmaceutica, S.A. DE C.V. GAP Class II 1991-02-11
K905465 STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE Angiosystems, Inc. KKX Class II 1991-02-11
K905422 PVC ROUND WOUND DRAINS Axiom Medical, Inc. GBX Class I 1991-02-11
K910192 AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1991-02-11
K905072 ALTAIR Pfizer Laser Systems GEX Class II 1991-02-07
K904244 SENSIDERM Ansell Intl. KGO Class I 1991-02-06
K905460 STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY Angiosystems, Inc. HMT Class II 1991-02-06
K905143 SKIN MARKER Aesculap, Inc. FZZ Class I 1991-02-06
K905240 VESSELOOPS Sparta Surgical Corp. KDC Class I 1991-02-06
K905462 PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES Angiosystems, Inc. LRP Class I 1991-02-06
K905027 CUP OUT Anspach Mfg., Inc. HSZ Class I 1991-02-05
K905108 CONTORNO(R), MODELS E AND ST Palex Intl. SA GEI Class II 1991-02-04
K903639 NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR Nidek, Inc. GEX Class II 1991-02-04

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.