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
76057–76080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2002
DRG REACTION CHAMBER/SAFETY TIP
K012003 · HEI
Doctor'S Research Group, Inc.
Obstetrics & Gynecology · 230d
Cleared Feb 12, 2002
AEROPEP
K012368 · BWF
Trudell Medical Intl.
Anesthesiology · 201d
Cleared Feb 12, 2002
ORION DIGITAL IMAGING SYSTEM
K012490 · OWB
Infimed, Inc.
Radiology · 193d
Cleared Feb 12, 2002
REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K012675 · JOW
Adven Medical
Cardiovascular · 182d
Cleared Feb 12, 2002
TWIN PLUS
K012976 · OLV
Grass-Telefactor Divison
Neurology · 160d
Cleared Feb 12, 2002
RUSCH MEMORY BAG
K013872 · GCJ
Rusch Intl.
General & Plastic Surgery · 83d
Cleared Feb 12, 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · MNH
Spinal Concepts, Inc.
Orthopedic · 81d
Cleared Feb 12, 2002
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
K013904 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 78d
Cleared Feb 12, 2002
WATERLASE MILLENNIUM
K013908 · MXF
Biolase Technology, Inc.
Dental · 78d
Cleared Feb 12, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 47d
Cleared Feb 12, 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · HRX
Tuta Healthcare Pty Limited
Orthopedic · 33d
Cleared Feb 12, 2002
E-SCAN XQ
K020164 · LNH
Biosound Esaote, Inc.
Radiology · 26d
Cleared Feb 12, 2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K020232 · CGA
Hypoguard USA, Inc.
Chemistry · 29d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295 · JWH
Implex Corp.
Orthopedic · 15d
Cleared Feb 12, 2002
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
K020301 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Feb 12, 2002
P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
K020362 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 8d
Cleared Feb 11, 2002
INCLUDER CLAMP
K010694 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 340d
Cleared Feb 11, 2002
STONELITH, MODEL V5
K011106 · LNS
Pck Electronic Industry and Trade Co,...
Gastroenterology & Urology · 306d
Cleared Feb 11, 2002
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
K011275 · LCL
Psychemedics Corp.
Toxicology · 291d
Cleared Feb 11, 2002
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
K012052 · JXG
Medtronic PS Medical
Neurology · 224d
Cleared Feb 11, 2002
PORTEX RING PESSARY PVC-NON STERILE
K012277 · HHW
Sims Portex , Ltd.
Obstetrics & Gynecology · 207d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467 · DSI
General Electric Medical Systems...
Cardiovascular · 194d
Cleared Feb 11, 2002
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · JOW
Sterilmed, Inc.
Cardiovascular · 185d
Cleared Feb 11, 2002
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS...
K012811 · MQH
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 173d