FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83233–83256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2000
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH,...
K000511 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Mar 13, 2000
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633
K000628 · MQE
Sims Portex , Ltd.
Obstetrics & Gynecology · 18d
Cleared Mar 13, 2000
CODMAN ETHISORB DURA PATCH
K991413 · GXQ
Johnson & Johnson Professionals, Inc.
Neurology · 325d
Cleared Mar 13, 2000
FERTILOSCOPY KIT FH 1.29/FTO 1.40
K992655 · HEW
Soprane S.A.
Obstetrics & Gynecology · 217d
Cleared Mar 13, 2000
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
K993024 · LJT
B. Braun of America, Inc.
General Hospital · 186d
Cleared Mar 13, 2000
HYLASINE
K993362 · EMX
Biomatrix, Inc.
Ear, Nose, Throat · 159d
Cleared Mar 13, 2000
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
K993568 · GWG
Machida Endoscope Co., Ltd.
Neurology · 144d
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS...
K994157 · DSP
Datascope Corp.
Cardiovascular · 95d
Cleared Mar 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 13, 2000
DYONICS ELECTROBLADE
K994365 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 77d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
United States Surgical, A Division of...
Orthopedic · 67d
Cleared Mar 10, 2000
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
K000058 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 60d
Cleared Mar 10, 2000
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
K000091 · JWH
Howmedica Osteonics Corp.
Orthopedic · 57d
Cleared Mar 10, 2000
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF...
K000165 · LYY
Ansell Perry
General Hospital · 51d
Cleared Mar 10, 2000
MODIFICATION TO SYNTHES USS
K000450 · MNI
Synthes Spine
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Mar 10, 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 17d
Cleared Mar 10, 2000
ROD TO ROD CROSS BRACES
K000634 · KWQ
Corin USA
Orthopedic · 14d
Cleared Mar 10, 2000
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992821 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 203d
Cleared Mar 10, 2000
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
K992850 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
K992856 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 163d
Cleared Mar 10, 2000
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE,...
K993805 · LZA
Best Manufacturing Company
General Hospital · 122d