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
76201–76224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2002
MODIFICATION TO VIEWSEND MEDICAL
K013994 · LLZ
Klt Telecom, Inc.
Radiology · 59d
Cleared Feb 01, 2002
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · DWC
Minntech Corp.
Cardiovascular · 58d
Cleared Feb 01, 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · CAF
Salter Labs
Anesthesiology · 53d
Cleared Feb 01, 2002
VACUETTE EDTA K2 TUBES
K014104 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 50d
Cleared Feb 01, 2002
SPECTRAL'S TROPONIN I
K014105 · MMI
Spectral Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 01, 2002
BIOTECH B990K VIVI WHEELCHAIR
K014198 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 42d
Cleared Feb 01, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
K020022 · MWI
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Feb 01, 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Feb 01, 2002
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
K020070 · EHD
Progeny, Inc.
Radiology · 23d
Cleared Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 18d
Cleared Feb 01, 2002
MODIFICATION TO ISOBAR SPINAL SYSTEM
K020245 · MNH
Scien'Tx USA, Inc.
Orthopedic · 8d
Cleared Jan 31, 2002
HUMPHREY OCT3
K012727 · IYO
Carl Zeiss Ophthalmic Systems, Inc.
Radiology · 169d
Cleared Jan 31, 2002
MATRIX DETACHABLE COILS
K012985 · HCG
Boston Scientific, Target
Neurology · 147d
Cleared Jan 31, 2002
GLOBALCARDIO
K013354 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 31, 2002
NUCLEOTOMY INTRADISCAL CATHETER
K013622 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 87d
Cleared Jan 31, 2002
APEX MEDICAL MINI TENS
K020032 · GZJ
Apex Medical Corp.
Neurology · 27d
Cleared Jan 31, 2002
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
K020077 · MSA
Augustine Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jan 30, 2002
SPIKED WASHER
K011583 · HTN
Synthes (Usa)
Orthopedic · 252d
Cleared Jan 30, 2002
DRG QUICKMIX
K011736 · GXP
Doctor'S Research Group, Inc.
General & Plastic Surgery · 239d
Cleared Jan 30, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · KWQ
Blackstone Medical, Inc.
Orthopedic · 202d
Cleared Jan 30, 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · KWI
Biomet, Inc.
Orthopedic · 176d
Cleared Jan 30, 2002
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
K012702 · JWH
Endotec, Inc.
Orthopedic · 169d
Cleared Jan 30, 2002
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 152d
Cleared Jan 30, 2002
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
K013167 · GZJ
Newcare Products, LLC
Neurology · 131d