FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92809–92832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1997
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
K971194 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 99d
Cleared Jul 09, 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · HRS
Osteonics Corp.
Orthopedic · 90d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · MBI
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Jul 09, 1997
EPITECH ISLAND DRESSINGS
K971337 · KMF
Rynel, Ltd. Inc.
General & Plastic Surgery · 90d
Cleared Jul 09, 1997
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · MAI
Arthrex, Inc.
Orthopedic · 89d
Cleared Jul 09, 1997
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
K971381 · KGO
Allegiance Healthcare Corp.
General Hospital · 86d
Cleared Jul 09, 1997
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE...
K971404 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 84d
Cleared Jul 09, 1997
OSTEONICS ALUMINA C-TAPER HEAD
K971409 · LZO
Osteonics Corp.
Orthopedic · 84d
Cleared Jul 09, 1997
HEADLOC CERAMIC HEAD
K971426 · LZO
Ortho Development Corp.
Orthopedic · 83d
Cleared Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · LZO
Ortho Development Corp.
Orthopedic · 82d
Cleared Jul 09, 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · HWC
Osteonics Corp.
Orthopedic · 64d
Cleared Jul 09, 1997
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
K971700 · ITX
Biosound, Inc.
Radiology · 62d
Cleared Jul 09, 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
K971815 · DQX
Guidant Corp.
Cardiovascular · 54d
Cleared Jul 09, 1997
SP4044 & SP4055 LUX MODULES
K972026 · ELC
Satelec
Dental · 37d
Cleared Jul 09, 1997
DISPOSABLE PATIENT RETURN ELECTRODE
K972269 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 22d
Cleared Jul 08, 1997
KAR
K961732 · MEH
Landos, Inc.
Orthopedic · 431d
Cleared Jul 08, 1997
RMI HEMOCONCENTRATOR PREFERENCE PACK
K970739 · KDI
Research Medical, Inc.
Gastroenterology & Urology · 130d
Cleared Jul 08, 1997
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K971342 · HWE
Disk Whisk, Inc.
Orthopedic · 89d
Cleared Jul 08, 1997
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550 · JWH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 08, 1997
FAR-EAST BARRIER GOWNS
K971702 · FYC
Far East Science & Technology...
General Hospital · 61d
Cleared Jul 08, 1997
X-RAY ASSIST BAR
K972000 · KPR
Ralph Lindel, D.C.
Radiology · 39d
Cleared Jul 08, 1997
NICAS(TM) ELECTRODE
K972001 · DRX
Ni Medical
Cardiovascular · 39d
Cleared Jul 08, 1997
NASAL AIRWAY SPLINT
K972092 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d