meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
41
Latest Decision
1982-01-05

Clearances · page 154 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813377 PS-ROUND SURG. DRAIN & CONNECTOR Pudenz-Schulte Medical Research Corp. GCY Class I 1982-01-05
K813422 SCALPEL Abco Dealers, Inc. GDX Class I 1982-01-05
K813207 K51,K52 ENVIRONMENT ENCLOSURE Kohler LEJ Class II 1981-12-31
K813312 UNIVERSAL SUCTION PUMP TYPE EUS Egnell, Inc. BTA Class II 1981-12-31
K813307 UVA HEX UNIT Sun Shanty, Inc. FTC Class II 1981-12-31
K813208 K60 HABITAT ENVIRONMENT ENCLOSURE Kohler LEJ Class II 1981-12-31
K813308 DOUBLE SEAL TUBEGUAZE STERILE BANDAGE Scholl, Inc. NAB Class I 1981-12-29
K813245 O'CONNOR HOOK PUNCH FORCEP Shutt Instruments GEN Class I 1981-12-29
K813078 CONTURA DISPOS. SURG. FACE MASK American Convertors Div., American Pharmaseal FXX Class II 1981-12-18
K813341 WOUND-EVAC Heritage Medical Products GCY Class I 1981-12-18
K813277 BOUNDARY DRAPE TAPE The Buckeye Cellulose Corp. KKX Class II 1981-12-18
K813063 FLAT DRAIN Sil-Med Corp. GBW Class I 1981-12-18
K813231 TOURNIQUET Aspen Laboratories, Inc. KCY Class I 1981-12-14
K813088 DESERET NEOLON SURGICAL GLOVES Warner-Lambert Co. KGO Class I 1981-12-14
K812444 RADIATION STERILIZATION FOR NEEDLE CNTR Devon Industries, Inc. GAB Class I 1981-12-14
K813095 GASTRIC JUICES SUCTION PUMP Egnell, Inc. BTA Class II 1981-12-09
K813103 ACKRAD INCISION & DRAIN SET Ackrad Laboratories KDD Class I 1981-12-09
K812997 FILTER FLOW MASK CAT. #350 Eldredge Mfg. Co. FXX Class II 1981-12-03
K812992 SURGICAL MASK South Mountain Medical FXX Class II 1981-12-03
K812996 FILTER FLOW MASK CAT. #300 Eldredge Mfg. Co. FXX Class II 1981-12-03
K813024 WA1000 Wallach Surgical Devices, Inc. GEH Class II 1981-12-03
K812132 STERILE SUTURE REMOVAL KIT E.M. Adams MCZ Class I 1981-12-01
K812390 NEUROSPONGE PADDIE Winn Hirsch & Assoc. GDY Class I 1981-11-24
K812391 NEUROSPONGES Winn Hirsch & Assoc. GDY Class I 1981-11-24
K812018 X-RAY DETECTABLE THREAD Isramed, Inc. GDY Class I 1981-11-20
K812876 SURGICAL PAWS M-W Laboratories, Inc. GDZ Class I 1981-11-20
K812819 ETHICON* SURGICAL SUTURES W/COMPRESS BOL ETHICON, Inc. KGS Class I 1981-11-20
K812017 X-RAY DETECTABLE BAND Isramed, Inc. GDY Class I 1981-11-20
K813093 RICHARDS ACETABULAR BRUSH Richard'S Medical Equip., Inc. HTR Class I 1981-11-20
K812396 ARTHRO-PREP REST Northwest Surgical Concepts, Inc. BWN Class I 1981-11-20
K812395 ARTHRO-PREP REST W/STAND Northwest Surgical Concepts, Inc. BWN Class I 1981-11-20
K812962 BOUNDARY SURGICAL DRAPE The Buckeye Cellulose Corp. KKX Class II 1981-11-20
K812875 SURGICAL LOOPS M-W Laboratories, Inc. GAD Class I 1981-11-20
K812785 VANCE-AMBROSE RESECTOSCOPE FORCEPS Vance Products, Inc. GEN Class I 1981-11-16
K812323 PDS* ABSORBABLE LIGATING CLIPS ETHICON, Inc. FZP Class II 1981-11-16
K812389 SURGICAL LOOPS Berkeley Medevices GAD Class I 1981-11-16
K812738 BOUNDARY PROCESS CHANGE The Buckeye Cellulose Corp. KKX Class II 1981-11-16
K812691 SILICONE IMPLANTS Sutter Biomedical, Inc. MDM Class I 1981-11-16
K812388 SURGICAL PAWS Berkeley Medevices GDJ Class I 1981-11-16
K812566 UNIVERSAL SUTURE PASSER Ortho Pared Instruments, Inc. GDL Class I 1981-11-10
K813072 E2502 & E2502B LECTROSWITCH Valleylab, Inc. GEI Class II 1981-11-10
K813071 E2508 DISPOSABLE HANDSWITCHING PENCIL Valleylab, Inc. GEI Class II 1981-11-10
K812814 ZEE SURGICAL INSTRUMENTS Zee Medical Products Co., Inc. GDZ Class I 1981-11-06
K812809 STERILE ADHERENT DRAPES Abco Dealers, Inc. KKX Class II 1981-11-06
K812769 TRIDENT #2001 Trident Surgical Corp. GEI Class II 1981-11-06
K812735 CLOTH SURGICAL GLOVES Medical Synergy KGO Class I 1981-11-06
K812831 SURGICAL DRESSINGS Foreign Trade Zone of Wisconsin GDY Class I 1981-11-06
K812713 DRAWER TEST Medmetric Corp. FTY Class I 1981-11-05
K812702 TECHNICATOR Cameron-Miller, Inc. GEI Class II 1981-11-05
K812722 SAFE GUARD Concept, Inc. GEI Class II 1981-11-05
K812707 STERILE DISSECTOR SPONGES-X-RAY DETECT Medspec Corp. GDY Class I 1981-11-02
K812710 STERILE LAPAROTOMY SPONGES-X-RAY DETECT Medspec Corp. GDY Class I 1981-11-02
K812437 150 DRIVER REAMER Black & Decker(Tm) GEY Class I 1981-11-02
K812711 STERILE GAUZE PADS 12PLY Medspec Corp. NAB Class I 1981-11-02
K812438 SAGITTAL SAW Black & Decker(Tm) GEY Class I 1981-11-02
K812663 SOLARIUM COMBINATION Tech-Pro, Inc. FTC Class II 1981-10-29
K812694 WHISK-R Medi-Spec GEE Class I 1981-10-26
K812637 ACMI BIPOLAR HEMOSTATIC SOURCE American Cystocope Makers, Inc. GEI Class II 1981-10-26
K812644 REPLACEABLE BATTERY PERFECTEMP 2 CAUT Key Medical, Inc. GEI Class II 1981-10-26
K812205 FORCEP Reznik Instruments GEN Class I 1981-10-26
K812651 X-RAY DETECTABLE LAP SPONGES Procter & Gamble Mfg. Co. GDY Class I 1981-10-20
K812405 STERILE TV CAMERA & CORD COVER Hydro-Med Products, Inc. KQM Class I 1981-10-20
K812020 EGNELL COMPACT, TYPE EHV Egnell, Inc. BTA Class II 1981-10-20
K811916 OPERATING ROOM KIT American Hospital Supply Corp. FSM Class I 1981-10-14
K812446 SUNLAMP The Richmond Light Co. FTC Class II 1981-10-13
K812675 DISPOSABLE SURGICAL FACE MASKS Irema USA , Ltd. FXX Class II 1981-10-13
K812203 ELECTROSURGICAL UNIT Reznik Instruments GEI Class II 1981-10-13
K812543 TANARAMA Marketing Consultants of America FTC Class II 1981-10-08
K812579 SUNTANNING HOME UNIT Tannhut FTC Class II 1981-10-08
K812516 SURGICAL BLADES & SCAPELS (SMPL. W/510K) Needle Industries(Usa), Inc. GES Class I 1981-10-02
K812448 UNI-THANE Unicare Systems, Inc. KKX Class II 1981-10-02
K812562 SURGICAL RETRACTOR & ELASTIC STAYS, DISP Humboldt Products GDG Class I 1981-10-02
K812521 SUNTANNING DEVICE (SEPAR. FROM K812225) Klafs Sunlight Corp. FTC Class II 1981-10-02
K812506 THE ARTHROFILE Dyonics, Inc. HTR Class I 1981-09-24
K812554 TOMAC STERILE DISP. LAP SPONGE American Convertors Div., American Pharmaseal GDY Class I 1981-09-24
K812125 LAPIN CLEAR CUT II Promed Corp. GEI Class II 1981-09-24
K801550 3M GERMICIDAL SURGICAL INCISE DRAPE 3M Company KKX Class II 1981-09-17
K812526 MICRO BLADE II Vxtra Corp. GES Class I 1981-09-16
K811632 UNSTERILIZED LAPAROTOMY SPONGES (CHINA) Robert I. Chien & Assoc., Inc. GDY Class I 1981-09-11
K811935 PROLENE POLYPROPYLENE LIGATING CLIP ETHICON, Inc. FZP Class II 1981-09-11
K812198 ACCESSORIES(PROBES, SUCTION TUBES, ETC.) Reznik Instruments GEI Class II 1981-09-11
K812291 ETHICON MULTIPLE LIGATING CLIP APPLIER ETHICON, Inc. GDO Class I 1981-09-11
K812234 STORZ/OLYMPUS MICROSCOPE SYSTEM Storz Instrument Co. EPT Class I 1981-09-11
K812105 ANOGO DISPOSABLE SHOE COVER Anago, Inc. BWP Class I 1981-09-11
K812210 CREAT BRAND WAGNER CHIN IMPLANT Aesthetech Corp. FWP Class II 1981-09-11
K811753 SURGEON'S GLOVES Travenol Laboratories, S.A. KGO Class I 1981-09-11
K810902 IP-758 BURN WOUND DRESSING Exopack NAE Class I 1981-09-11
K812071 RK IV SURGICAL BLADES Santa Barbara Medco, Inc. GES Class I 1981-08-31
K812069 BORES* DEPTH GAUGE Santa Barbara Medco, Inc. FTY Class I 1981-08-31
K812160 MICROSURGICAL BLADE Vxtra Corp. GES Class I 1981-08-31
K811965 VISITEC NEEDLE RANGE (GASTERUROLOGY) Visitec Co. FHR Class I 1981-08-25
K811871 BACTERICIDAL INCISE DRAPE Surgikos, Inc. KKX Class II 1981-08-20
K812070 BORES* ADJUSTABLE BLADE HOLDER Santa Barbara Medco, Inc. GDZ Class I 1981-08-18
K811870 UVA SUN TANNING EQUIPMENT Cpc Systems, Inc. FTC Class II 1981-08-17
K811585 F72T12/BL-S/HO UVA SUNLAMP Westinghouse Electric Corp. FTC Class II 1981-08-13
K811506 MICRO-AIRE REPLACEMENT SAW BLADES Micro-Aire Surgical Instruments, Inc. GFA Class I 1981-08-13
K811996 GATOR DRAPES The Anspach Effort, Inc. KKX Class II 1981-08-13
K811586 F72T12/BL-S/SHO-O UVA SUNLAMP Westinghouse Electric Corp. FTC Class II 1981-08-13
K811627 ARROW PERITONEAL LAVAGE CATHERIZATION K Arrow Intl., Inc. GBW Class I 1981-08-10
K811769 LAPAROTOMY PADS South Mountain Medical GDY Class I 1981-08-07

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