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
74713–74736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2002
BODY FORCE, MODEL BT 6000
K020211 · JOW
Composites Solutions, Inc.
Cardiovascular · 157d
Cleared Jun 28, 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · DRX
Medicotest A/S
Cardiovascular · 143d
Cleared Jun 28, 2002
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
K020932 · CAF
Sunrise Medical
Anesthesiology · 98d
Cleared Jun 28, 2002
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
K021097 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 85d
Cleared Jun 28, 2002
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
K021140 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021229 · DDR
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Jun 28, 2002
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE...
K021290 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 66d
Cleared Jun 28, 2002
MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL...
K021305 · DXN
Microlife Corp.
Cardiovascular · 65d
Cleared Jun 28, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM...
K021345 · FGE
Cordis Corp.
Gastroenterology & Urology · 60d
Cleared Jun 28, 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · IPF
Apex Medical Corp.
Physical Medicine · 30d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · CGA
Lifescan, Inc.
Chemistry · 31d
Cleared Jun 27, 2002
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
K003720 · KPL
Lifestream Purfication Systems, LLC
Gastroenterology & Urology · 570d
Cleared Jun 27, 2002
REPROCESSED ELECTROSURGICAL ELECTRODES
K012669 · GEI
Surgical Instruments Service and...
General & Plastic Surgery · 318d
Cleared Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613 · LZU
Oasis Medical, Inc.
Ophthalmic · 234d
Cleared Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · GKP
Dade Behring, Inc.
Hematology · 93d
Cleared Jun 27, 2002
REX, VERSION 1.0
K021099 · LLZ
Pointdx, Inc.
Radiology · 84d
Cleared Jun 27, 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jun 27, 2002
ORS-1000LD
K021288 · LHC
O.R. Solutions, Inc.
General Hospital · 65d
Cleared Jun 27, 2002
H12+HOLTER RECORDER
K021373 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 57d
Cleared Jun 27, 2002
EXTENSION SET LIGHT-SAFE, MODEL BC565
K021480 · FPA
Codan US Corp.
General Hospital · 50d
Cleared Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
K021532 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
K021535 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607 · JIT
Reference Diagnostics, Inc.
Immunology · 42d
Cleared Jun 27, 2002
RDI HS CRP KIT
K021609 · DCK
Reference Diagnostics, Inc.
Chemistry · 42d