Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
55897–55920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2008
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493,...
K080634 · DDG
Beckman Coulter, Inc.
Immunology · 158d
Cleared Aug 11, 2008
IEC MEDSIGHT AND MEDBRIGHT
K080809 · FET
Innovative Endoscopy Components, LLC
Gastroenterology & Urology · 143d
Cleared Aug 11, 2008
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K081315 · LZA
Gx Corporation Sdn Bhd
General Hospital · 94d
Cleared Aug 11, 2008
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445 · FLL
Taidoc Technology Corporation
General Hospital · 81d
Cleared Aug 11, 2008
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
K081633 · FXX
Primed Medical Products, Inc.
General Hospital · 61d
Cleared Aug 11, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K082059 · PNO
Angioscore, Inc.
Cardiovascular · 21d
Cleared Aug 11, 2008
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
K082148 · HSB
Synthes (Usa)
Orthopedic · 12d
Cleared Aug 08, 2008
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
K073664 · MDM
Injectimed, Inc.
General & Plastic Surgery · 226d
Cleared Aug 08, 2008
EMBLETTA GOLD
K073682 · MNR
Embla Systems, Inc.
Anesthesiology · 224d
Cleared Aug 08, 2008
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
K080167 · CEC
Siemens Healthcare Diagnostics
Chemistry · 198d
Cleared Aug 08, 2008
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
K080273 · JJX
Fujirebio Diagnostics Texas, Inc.
Chemistry · 189d
Cleared Aug 08, 2008
MAPERSOL
K080432 · KDN
Preservation Solutions, Inc.
Gastroenterology & Urology · 171d
Cleared Aug 08, 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · KRA
Cook, Inc.
Cardiovascular · 144d
Cleared Aug 08, 2008
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 123d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · DQX
Boston Scientific Corp
Cardiovascular · 120d
Cleared Aug 08, 2008
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK...
K081159 · DXN
Harvard Medical Devices , Ltd.
Cardiovascular · 116d
Cleared Aug 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST -...
K081182 · JWY
Siemens
Microbiology · 105d
Cleared Aug 08, 2008
DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4
K081200 · EIH
Global Top, Inc.
Dental · 102d
Cleared Aug 08, 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081299 · DDG
Siemens Healthcare Diagnostics, Inc.
Immunology · 92d
Cleared Aug 08, 2008
APPROACH CTO WIRE GUIDE
K081337 · DQX
Cook Incorporated
Cardiovascular · 87d
Cleared Aug 08, 2008
ATRILAZE LASER ABLATION SYSTEM
K081457 · GEX
Medical Cv, Inc.
General & Plastic Surgery · 77d
Cleared Aug 08, 2008
SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
K081476 · KKX
Surgical Concept Designs
General Hospital · 73d
Cleared Aug 08, 2008
INSTRUMED RONGEUR
K081651 · HAE
Instrumed International, Inc.
Neurology · 57d
Cleared Aug 08, 2008
PKS OMNI INSTRUMENT
K081766 · GEI
Gyrus-Acmi L.P.
General & Plastic Surgery · 49d