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
91537–91560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1997
UAS ULTRASONIC ASPIRATOR SYSTEM
K971580 · LFL
Wells Johnson Co.
General & Plastic Surgery · 223d
Cleared Dec 09, 1997
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER
K972496 · KNW
Tao & Tao Technologyt, Inc.
Gastroenterology & Urology · 159d
Cleared Dec 09, 1997
ULTRACELL NEURO SPONGES
K973083 · HBA
Ultracell Medical Technologies, Inc.
Neurology · 113d
Cleared Dec 09, 1997
CLINITEX STOCKINETTE
K973417 · LGF
Clinitex Medical Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
CLINITEX CAST PADDING
K973420 · LGF
Clinitex Medical Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
ENFRESH TONGUE BRUSH
K973424 · LCN
Enfresh Products, LLC
Dental · 90d
Cleared Dec 09, 1997
SURGIFLATOR-30
K973432 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 90d
Cleared Dec 09, 1997
VISTA HEAD MOUNTED DISPLAY
K973436 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Dec 09, 1997
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · HRS
Osteonics Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
TORNIER CEMENT RESTRICTOR
K973453 · JDI
Tornier
General & Plastic Surgery · 89d
Cleared Dec 09, 1997
ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K973461 · KGO
Ansell Perry
General Hospital · 88d
Cleared Dec 09, 1997
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER...
K973470 · GEX
Lumenis, Inc.
General & Plastic Surgery · 88d
Cleared Dec 09, 1997
EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM
K973576 · GEX
Epulse Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Dec 09, 1997
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
K974158 · KNW
Ortho Development Corp.
Gastroenterology & Urology · 36d
Cleared Dec 08, 1997
COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
K963518 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 461d
Cleared Dec 08, 1997
FREEDOM
K973089 · EBF
Southern Dental Industries, Inc.
Dental · 112d
Cleared Dec 08, 1997
WAVE
K973091 · EBF
Southern Dental Industries, Inc.
Dental · 112d
Cleared Dec 08, 1997
STAE
K973092 · KLE
Southern Dental Industries, Inc.
Dental · 112d
Cleared Dec 08, 1997
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
K973406 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Dec 08, 1997
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
K973412 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 08, 1997
ENDO ANALYZER, MODEL 8005
K973439 · EAT
Sybron Dental Specialties, Inc.
Dental · 89d
Cleared Dec 08, 1997
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · CAF
Invacare Corp.
Anesthesiology · 87d
Cleared Dec 08, 1997
3M CDI H/S CUVETTES WITH HEPARON TREATMENT
K973472 · DRY
3M Healthcare
Cardiovascular · 87d
Cleared Dec 08, 1997
CLEARVIEW BLOWER/MISTER
K973485 · FQH
Dlp, Inc.
General Hospital · 84d