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

Filters: Cleared only ×
175,820 results
42865–42888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2012
FLO-GUARD BREATHING FILTER
K121026 · CAH
Intersurgical, Inc.
General Hospital · 212d
Cleared Nov 02, 2012
FLIGHTPLAN FOR LIVER
K121200 · LLZ
Ge Healthcare
Radiology · 197d
Cleared Nov 02, 2012
VITREAADVANCED
K121213 · LLZ
Vital Images, Inc.
Radiology · 196d
Cleared Nov 02, 2012
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI)...
K121539 · NJR
Cepheid
Microbiology · 162d
Cleared Nov 02, 2012
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
K121878 · OCL
Medtronic, Inc.
Cardiovascular · 127d
Cleared Nov 02, 2012
NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA...
K122192 · NHA
Straumann USA, LLC
Dental · 101d
Cleared Nov 02, 2012
BARD PTV DILATATION CATHETER
K122367 · OMZ
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2012
TRUSCULPT
K122389 · PBX
Cutera, Inc.
General & Plastic Surgery · 87d
Cleared Nov 02, 2012
TANGO M2 BLOOD PRESSURE MONITOR
K122401 · DXN
Suntech Medical, Inc.
Cardiovascular · 87d
Cleared Nov 02, 2012
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH...
K122436 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 84d
Cleared Nov 02, 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636 · LPH
Encore Medical, L.P.
Orthopedic · 65d
Cleared Nov 02, 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K122646 · MOS
Invivo Corporation
Radiology · 64d
Cleared Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 39d
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021 · LJN
Bio-Rad Laboratories
Microbiology · 36d
Cleared Nov 02, 2012
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
K123179 · PAH
C.R. Bard, Inc.
Gastroenterology & Urology · 24d
Cleared Nov 02, 2012
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K123185 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 23d
Cleared Nov 02, 2012
SURFFLASH(R) PLUS SAFETY I.V. CATHETER
K123267 · FOZ
Kofu Factory of Terumo Corp.
General Hospital · 14d
Cleared Nov 01, 2012
FRONTIER SADL INTERBODY FUSION DEVICE
K112700 · OVD
Frontier Medical Devices, Inc.
Orthopedic · 412d
Cleared Nov 01, 2012
EXTENDED LIFE BATTERY
K120350 · MKJ
Aed Battery Exchange, LLC
Cardiovascular · 269d
Cleared Nov 01, 2012
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K121315 · FWP
Howmedica Osteonics Corp.
General & Plastic Surgery · 183d
Cleared Nov 01, 2012
LEVANT, HOMEGLIDE
K121560 · ILK
Thyssenkrupp Accessibility B.V.
Physical Medicine · 156d
Cleared Nov 01, 2012
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K121793 · LXB
Audifon-USA, Inc.
Ear, Nose, Throat · 135d
Cleared Nov 01, 2012
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 107d
Cleared Nov 01, 2012
PRESSURIZED INFUSION PUMP
K122294 · FFX
Mui Scientific
Gastroenterology & Urology · 93d