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
73801–73824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 46d
Cleared Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K023558 · CHH
Polymer Technology Systems, Inc.
Chemistry · 23d
Cleared Nov 15, 2002
PHASEAL
K023747 · LHI
Carmel Pharma Ab.
General Hospital · 7d
Cleared Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470 · MWJ
General Electric Medical Systems...
Cardiovascular · 190d
Cleared Nov 14, 2002
LUTHER SAFETY HUBER NEEDLE SET
K021565 · FPA
Luther Research Partners
General Hospital · 185d
Cleared Nov 14, 2002
VENTED CEMENT RESTRICTOR
K022729 · JDX
Amedica Corp.
Orthopedic · 90d
Cleared Nov 14, 2002
V TENS PLUS
K022731 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Nov 14, 2002
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A...
K022740 · MLD
Datex-Ohmeda
Cardiovascular · 87d
Cleared Nov 14, 2002
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K022753 · JOW
Medical Device Services
Cardiovascular · 87d
Cleared Nov 14, 2002
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
K022900 · JEQ
John O. Butler Co.
Dental · 72d
Cleared Nov 14, 2002
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
K022934 · BZD
Gottlieb Weinmann Geraete Fuer...
Anesthesiology · 71d
Cleared Nov 14, 2002
CARDIOTOUCH-3000
K023034 · LOS
Bionet Company, Ltd.
Cardiovascular · 63d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434 · LHQ
Dorex, Inc.
Radiology · 30d
Cleared Nov 14, 2002
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF...
K023437 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Nov 14, 2002
SKINTACT ECG ELECTRODE
K023503 · DRX
Leonhard Lang GmbH
Cardiovascular · 27d
Cleared Nov 13, 2002
HEX-LOCK TEMPORARY ABUTMENT
K014050 · DZE
Sulzer Dental, Inc.
Dental · 338d
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703 · JWH
Howmedica Osteonics Corp.
Orthopedic · 254d
Cleared Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
K021060 · FKP
Fresenius Medical Care North America
Gastroenterology & Urology · 225d
Cleared Nov 13, 2002
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 183d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · MDM
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 107d
Cleared Nov 13, 2002
PHYSICAL MONITORING REGISTRATION UNIT
K022719 · IKN
Maryrose Cusimano, Ph.D./Phil Reaston
Neurology · 90d
Cleared Nov 13, 2002
AMT POLYAXIAL PEDICLE SCREW
K022768 · MNI
Micron Precision Engineering, Inc.
Orthopedic · 84d
Cleared Nov 13, 2002
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
K022769 · JJX
Bionostics, Inc.
Chemistry · 84d