meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
46
Latest Decision
1978-07-27

Clearances · page 161 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K780998 SCALPEL Isolab, Inc. GDX Class I 1978-07-27
K780585 SURGICAL LASER Laser Industries , Ltd. GEX Class II 1978-07-19
K780574 SUTURE CUTTER Laschal Instrument Corp. FZT Class I 1978-07-17
K781101 ELECTROSURGICAL UNIT 75 Ritter Co. GEI Class II 1978-07-17
K780708 AUTOMATIC RETRACTOR HOLDER Great Eastern Lumber Co., Inc. GAD Class I 1978-07-17
K781082 CAST BLOCK Orthopedic Equipment Co., Inc. JEB Class I 1978-07-07
K780880 Y-TYPE BLOOD SET Abbott Laboratories KDC Class I 1978-06-30
K780718 SOF-WICKLAP PAD Johnson & Johnson Professionals, Inc. GDY Class I 1978-06-28
K780695 AUTO SUTURE DISPOSABLE STAPLING INSTRU. United States Surgical, A Division of Tyco Healthc GDW Class II 1978-06-22
K780977 SINGLE USE BLADE ELECTRODE Aspen Laboratories, Inc. GEI Class II 1978-06-22
K780788 IRRIGATION CATHETER Shiley, Inc. GBX Class I 1978-06-22
K780924 ELECTROSURGICAL GROUNDING PAD CABLE Johnson & Johnson Professionals, Inc. GEI Class II 1978-06-22
K780607 MASK, SURGEONS Abco Dealers, Inc. FXX Class II 1978-06-22
K780978 SINGLE USE ACTIVE ELECTRODE HANDLE Aspen Laboratories, Inc. GEI Class II 1978-06-22
K780976 SINGLE USE BALL ELECTRODE Aspen Laboratories, Inc. GEI Class II 1978-06-22
K780975 SINGLE USE NEEDLE ELECTRODE Aspen Laboratories, Inc. GEI Class II 1978-06-22
K780887 IMPROVED DISPOSABLE HYPODERMIC NEEDLE Pharmaseal Div., Baxter Healthcare Corp. GAA Class I 1978-06-22
K780846 DRAPING MATERIAL, COLBALT 60 STERILE Kimberly-Clark Corp. KKX Class II 1978-06-19
K780871 ARTERIAL LINE KIT Argon Medical Corp. GDY Class I 1978-06-14
K780289 NERVE APPROXIMATER Edward Weck, Inc. GDG Class I 1978-06-14
K780764 NON-STERILE FOLDED GAUZE The Owenby Co. NAB Class I 1978-06-06
K780795 GAUZE SPONGES Abco Dealers, Inc. NAB Class I 1978-06-06
K780594 VELKET TOURNIQUET Abco Dealers, Inc. GAX Class I 1978-06-06
K780624 CULDOCENTESIS TRAY Cutter Laboratories, Inc. GAA Class I 1978-05-26
K780609 MASK, ISOLATION Abco Dealers, Inc. FXX Class II 1978-05-26
K780759 MODEL 902 STAND Applied Medical Research FSH Class I 1978-05-19
K780348 EPILATION TYPE DEVICE Mehl, Thomas L. KCX Class I 1978-05-18
K780586 MICROCLIP, WILLIAMS Richard'S Medical Equip., Inc. GDW Class II 1978-05-16
K780771 MICRO RASPS Amsco Co. HTR Class I 1978-05-16
K780590 SHOE COVERS Abco Dealers, Inc. FXP Class I 1978-05-09
K780605 ISOLATION GOWN Abco Dealers, Inc. FYC Class II 1978-05-09
K780723 OTOSCOPE SPECULA Abco Dealers, Inc. EPY Class I 1978-05-09
K772393 CARROLL TENDON RETRIEVER Edward Weck, Inc. GEN Class I 1978-05-09
K780645 HMD-2000 BATTERY-POWERED MINI-DRILL, THE Medishield, Inc. KIJ Class I 1978-05-03
K780666 DAYSTAR SELECTRA & SELECTRA/ORBITER Castle Co. FSY Class II 1978-04-27
K780549 NON-STICK PADS National Patent Development Corp. NAB Class I 1978-04-19
K780575 LASCHAL SCISSOR Laschal Instrument Corp. FZT Class I 1978-04-18
K780429 TOURNEQUET, NON-PNEUMATIC Hemox, Inc. GAX Class I 1978-04-18
K780255 NEEDLE DRIVER Scanlan Intl., Inc. GFC Class I 1978-04-18
K780259 CATHETERIZATION TRAY & KIT Argon Medical Corp. KGZ Class I 1978-04-18
K780337 THERMOLYSIS GENERATOR Clare, Inc. KCW Class I 1978-04-12
K780488 INSTRUMENT AND ACCESSORY KIT American Hospital Supply Corp. KDD Class I 1978-04-12
K780394 GAUZE FLUFF The Torrent Corp. NAB Class I 1978-04-10
K780405 INFANT ELECTROSURGICAL GROUNDING PAD New Dimensions IN Medicine, Inc. JOS Class II 1978-04-05
K772387 LEAD HAND Edward Weck, Inc. KKX Class II 1978-04-05
K780336 URINE SAMPLE KIT American Hospital Supply Corp. KDD Class I 1978-04-03
K780419 SUBCLAVIAN TRAY Concord Laboratories, Inc. KGO Class I 1978-03-27
K780162 DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 Cavitron Corp. FTA Class II 1978-03-27
K780408 MICRONET LIGHT DRESSING SPONGE Kendall Research Center NAB Class I 1978-03-22
K780399 INSTRUMENT CLEANING BRUSH Ransom and Randolph KDC Class I 1978-03-17
K780293 ELECTROSURGICAL UNIT Ritter Co. HAM Class II 1978-03-14
K772373 ANDERSON-NEIVERT OSTEOTOME Edward Weck, Inc. KDG Class I 1978-03-09
K772374 SILVER OSTEOTOME Edward Weck, Inc. KDG Class I 1978-03-09
K772394 KALRN FACE-LIFE SCISSORS Edward Weck, Inc. FZI Class II 1978-03-09
K772378 NEIVS TRACHEOTOMY RETRACTOR Edward Weck, Inc. GAD Class I 1978-03-09
K772376 NEIVERT OSTEOTOME Edward Weck, Inc. KDG Class I 1978-03-09
K772383 LONG JEWELERS FORCEPS Edward Weck, Inc. GEN Class I 1978-03-09
K772395 DAVIS RHYTIDECTOMY Edward Weck, Inc. FZI Class II 1978-03-09
K780291 ULNAR-RADIAL APPROXIMATER Edward Weck, Inc. GDJ Class I 1978-02-28
K780298 ELECTRO-SURGICAL GROUNDING PAD Johnson & Johnson Professionals, Inc. GEI Class II 1978-02-28
K780288 BRACHEAL-LARGE VESSEL CLIP Edward Weck, Inc. GDJ Class I 1978-02-28
K780290 ULNAR-RADIAL CLIP Edward Weck, Inc. GDJ Class I 1978-02-28
K780286 BRACHIAL-LARGE VESSEL APPROXIMATOR Edward Weck, Inc. GDJ Class I 1978-02-28
K780118 ELECTRODE, DISPERSIVE, DISP. NEOPAD Neomed Corp. HAM Class II 1978-02-23
K780206 GENERATOR, ELECTROSURGICAL Valleylab, Inc. GEI Class II 1978-02-21
K780169 MASK, SURGICAL Convertors FXX Class II 1978-02-13
K780152 FACELIFT SCISSORS Edward Weck, Inc. FZT Class I 1978-02-02
K780153 HOUSE SUCTION IRRIGATOR Edward Weck, Inc. JYC Class I 1978-02-02
K780139 PNEUMATIC POWERED BUR North Palm Beach Orthodepic Assoc. HSZ Class I 1978-02-01
K771218 INTRA-ARTICULAR SHAVER Dyonics, Inc. KIJ Class I 1978-02-01
K780135 CEMENT EXTRACTION INSTRUMENT SET Orthopedic Equipment Co., Inc. KDG Class I 1978-01-31
K772288 CATHETER, CHOLANGIOGRAM, OPERATIVE Gesco Intl., Inc. GBZ Class I 1978-01-30
K780036 TOWEL, DRAPE, BOUNDARY Procter & Gamble Mfg. Co. KKX Class II 1978-01-24
K780076 EPILATOR, ELECTRONIC MODEL SE-2 R. A. Fischer Co. Corp. KCW Class I 1978-01-24
K772266 INSTRUMENT TRAY Med Fusion Systems, Inc. FSM Class I 1978-01-20
K772385 THIN-BLADED NASAL SPECULUM Edward Weck, Inc. EPY Class I 1978-01-17
K772370 BARRAQUER OVAL SPECULUM-VARIOUS SIZES Edward Weck, Inc. EPY Class I 1978-01-17
K772380 FARRIOR OVAL SPECULUM Edward Weck, Inc. EPY Class I 1978-01-17
K771016 INTERMEDULLARY BRUSH Howmedica Corp. HTR Class I 1978-01-12
K772293 BONE MARROW BIOPSY DEVICE Radiation Development Co., Inc. GDM Class I 1978-01-03
K772321 ARTHROSTRESS Mtd, Inc. JEB Class I 1978-01-03
K772322 DEPILATORY, ELECTRONIC Dura Corp., The KCX Class I 1978-01-03
K772324 WIREDRIVER American Sterilizer Co. HSZ Class I 1978-01-03
K772188 FSH RIA KIT (125I) Diagnostic Products Corp. FSH Class I 1977-12-22
K772301 LAPAROSCOPY DRAPE, BOUNDARY Procter & Gamble Mfg. Co. FZT Class I 1977-12-20
K772286 FORCEPS, SUTURE, AUTO Hartmann Group, Inc. GDO Class I 1977-12-20
K772232 LIQUID NITROGEN SPRAY UNIT Gilmore Liquid Air Co. GEH Class II 1977-12-15
K771702 VESSEL-STABILIZER Med General KDC Class I 1977-12-13
K771589 AUTO SUTURE U. S. Surgical Corp. GDJ Class I 1977-12-13
K772235 HAND CONTROL ACCESS.-ELECTROSURG. UNITS Cameron-Miller, Inc. GEI Class II 1977-12-13
K771701 VESSEL-CLUDE Med General GDJ Class I 1977-12-13
K772199 CAUTERIES, HOT WIRE, DISP. Intermedics, Inc. GEI Class II 1977-12-13
K772182 SURGICAL GOWN, REINFORCED Surgikos, Inc. FYA Class II 1977-12-08
K771320 CRYOSURGICAL EQUIPMENT A.S.M.O.T. GEH Class II 1977-12-06
K771574 LEE ASPIRATION NEEDLE Radiation Development Co., Inc. GDM Class I 1977-12-06
K771784 IOPSY TRAY FOR SOFT TISSUE BIOPSY Bd Becton Dickinson Vacutainer Systems Preanalytic GAA Class I 1977-11-30
K771639 ELECTROSURGICAL GENERATOR Cameron-Miller, Inc. GEI Class II 1977-11-29
K771413 LIGACLIP MULTIPLE LIGATING CLIPS ETHICON, Inc. FZP Class II 1977-11-28
K771865 DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 Castle Co. FSY Class II 1977-11-28
K771861 CATHETER, CEBTRAL VENOUS, 2N1501 Travenol Laboratories, S.A. JCY Class I 1977-11-28

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