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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47305–47328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2011
SUGLUE-10
K110508 · EMA
3M Espe AG
Dental · 101d
Cleared Jun 03, 2011
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K110645 · DSB
Sonosite,Inc.
Cardiovascular · 91d
Cleared Jun 03, 2011
EMULSION SB
K110732 · FRO
Prugen IP Holdings, Inc.
General & Plastic Surgery · 79d
Cleared Jun 03, 2011
AMSCO WARMING CABINET
K110769 · LGZ
STERIS Corporation
General Hospital · 77d
Cleared Jun 03, 2011
ACE STAPLER AND CARTRIDGE
K110829 · OCW
Barosense, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 03, 2011
BILLY BOY MALE LATEX CONDOM
K111093 · HIS
Mapa GmbH
Obstetrics & Gynecology · 45d
Cleared Jun 03, 2011
LUMINOS AGILE
K111292 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Jun 03, 2011
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH...
K111442 · GAM
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 10d
Cleared Jun 03, 2011
DISCOVERY NM 630
K111445 · KPS
Ge Healthcare
Radiology · 10d
Cleared Jun 02, 2011
INVADER FACTOR II
K100943 · NPR
Hologic, Inc.
Pathology · 422d
Cleared Jun 02, 2011
FRACTORA
K102461 · GEI
Invasix , Ltd.
General & Plastic Surgery · 279d
Cleared Jun 02, 2011
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
K102479 · MQB
Alara, Inc.
Radiology · 276d
Cleared Jun 02, 2011
IGX PLEX CELIAC QUALITATIVE ASSAY
K102490 · MVM
Sqi Diagnostics Systems
Immunology · 275d
Cleared Jun 02, 2011
WATCH-PAT 200S-3 (WP200S-3)
K102567 · MNR
Itamar Medical , Ltd.
Anesthesiology · 268d
Cleared Jun 02, 2011
AOS ORION IR-192 SOURCE CABLE
K102811 · KXK
Alpha-Omega Services, Inc.
Radiology · 247d
Cleared Jun 02, 2011
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
K103205 · KWP
Alphatec Spine, Inc.
Orthopedic · 213d
Cleared Jun 02, 2011
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
K103548 · JIT
Siemens Healthcare Diagnostics, Inc.
Immunology · 181d
Cleared Jun 02, 2011
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K103578 · BZK
Respironics Novametrix, LLC
Anesthesiology · 178d
Cleared Jun 02, 2011
REGUIS SIGMA
K103703 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 164d
Cleared Jun 02, 2011
OMNI II PATIENT MONITOR
K103737 · MWI
Infinium Medical
Cardiovascular · 162d
Cleared Jun 02, 2011
HET BIPOLAR ELECTROCAUTERY FORCEPS
K110143 · GEI
Het Systems, LLC
General & Plastic Surgery · 135d
Cleared CT Jun 02, 2011
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM...
K110617 · LOX
Abbott Vascular
Cardiovascular · 91d
Cleared Jun 02, 2011
APTUS CANNULATED COMPRESSION SCREWS
K110658 · HWC
Medartis AG
Orthopedic · 87d
Cleared Jun 02, 2011
TAMPAX C PLASTIC TAMPONS, UNSCENTED
K110669 · HEB
The Procter & Gamble Co.
Obstetrics & Gynecology · 85d