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
87913–87936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1998
BARD HYDROPHILLIC COATED GUIDE WIRE
K974713 · DQX
C.R. Bard, Inc.
Cardiovascular · 301d
Cleared Oct 14, 1998
CARDIOPAL MODEL NUMBER PM20
K981119 · DXH
Medicomp, Inc.
Cardiovascular · 201d
Cleared Oct 14, 1998
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K981697 · DPS
Cambridge Heart, Inc.
Cardiovascular · 156d
Cleared Oct 14, 1998
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
K981744 · BZD
W. Keith Thornton, D.D.S.
Anesthesiology · 149d
Cleared Oct 14, 1998
ECG ELECTRODES APRON
K982470 · DRX
Tapuz Medical Technology , Ltd.
Cardiovascular · 90d
Cleared Oct 14, 1998
EXCEL AMBULATORY EEG
K982479 · GWQ
Excel Tech. , Ltd.
Neurology · 90d
Cleared Oct 14, 1998
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT,...
K982487 · BZC
Cardiopulmonary Technologies, Inc.
Anesthesiology · 89d
Cleared Oct 14, 1998
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
K982935 · KXT
Beckman Coulter, Inc.
Toxicology · 54d
Cleared Oct 13, 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
K974890 · MGP
Acutek Adhesive Specialties, Inc.
General & Plastic Surgery · 287d
Cleared Oct 13, 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
K974892 · MGP
Acutek Adhesive Specialties, Inc.
General & Plastic Surgery · 287d
Cleared Oct 13, 1998
PHILIPS EASYGUIDE
K980820 · HAW
Philips Medical Systems, Inc.
Neurology · 224d
Cleared Oct 13, 1998
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS...
K981634 · LTJ
Biocircuits Corp.
Immunology · 158d
Cleared Oct 13, 1998
TITANIUM HEMOSTATIC CLIP
K981645 · FZP
Vitalitec Int'L., Inc.
General & Plastic Surgery · 158d
Cleared Oct 13, 1998
COAGULATION FACTOR V DEFICIENT PLASMA
K981709 · GJT
Dade Behring, Inc.
Hematology · 162d
Cleared Oct 13, 1998
BREATHE EASY, MODELS AD AND CD
K981841 · FRF
Respiraid , Ltd.
General Hospital · 140d
Cleared Oct 13, 1998
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K982688 · MIB
Spectrum Designs, Inc.
General & Plastic Surgery · 71d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871 · DKB
Dade Behring, Inc.
Toxicology · 60d
Cleared Oct 13, 1998
BTF THIN FILM WOUND DRESSING
K982939 · MGP
Bioderm, Inc.
General & Plastic Surgery · 53d
Cleared Oct 13, 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982 · HRS
Biomet, Inc.
Orthopedic · 48d
Cleared Oct 13, 1998
INNOVASIVE TIBIAL FASTENER
K983056 · MBI
Innovasive Devices, Inc.
Orthopedic · 42d
Cleared Oct 13, 1998
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
K983175 · LYY
Ultrawin Sdn Bhd
General Hospital · 33d
Cleared Oct 09, 1998
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
K981323 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 179d
Cleared Oct 09, 1998
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
K981591 · FAD
International Regulatory Consultants
Gastroenterology & Urology · 158d
Cleared Oct 09, 1998
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY
K981597 · IYE
Radionics, Inc.
Radiology · 158d