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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
58177–58200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2007
VASCUTRAK II PTA DILATATION CATHETER
K073025 · PNO
Thermopeutix, Inc. Dba Ymed, Inc.
Cardiovascular · 14d
Cleared Nov 08, 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264 · FGE
Medtronic Vascular
Gastroenterology & Urology · 461d
Cleared Nov 08, 2007
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
K070569 · DZE
Dio Department Dsi, Inc.
Dental · 253d
Cleared Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
K071957 · OTP
Boston Scientific Corp
Obstetrics & Gynecology · 115d
Cleared Nov 08, 2007
VITASCORE
K072014 · MNR
Vitascore B.V.
Anesthesiology · 108d
Cleared Nov 08, 2007
GUNTHER TULIP VENA CAVA FILTER
K072240 · DTK
Cook, Inc.
Cardiovascular · 87d
Cleared Nov 08, 2007
EMULATE ADVANCED
K072245 · ELW
Cavex Holland BV
Dental · 87d
Cleared Nov 08, 2007
STERICAN HYPODERMIC NEEDLES
K072247 · FMI
B.Braun Medical, Inc.
General Hospital · 87d
Cleared Nov 08, 2007
AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
K072359 · MSH
Aearo Company
General Hospital · 78d
Cleared Nov 08, 2007
CONFORMIS UNI-CONDYLAR KNEE SYSTEM
K072586 · HSX
Conformis, Inc.
Orthopedic · 56d
Cleared Nov 08, 2007
NEXFIX COMPRESSION PIN
K072710 · JDW
Nexa Orthopedics, Inc.
Orthopedic · 44d
Cleared Nov 08, 2007
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
K072960 · LLZ
Cdp, Ltd.
Radiology · 20d
Cleared Nov 07, 2007
TENSION BAND ANTERIOR SPINAL SYSTEM
K071151 · KWQ
Spinal Instrumentation Simplification...
Orthopedic · 196d
Cleared Nov 07, 2007
ISCALERT SENSOR SYSTEM
K071165 · CCC
Alertis Medical AS
Anesthesiology · 195d
Cleared Nov 07, 2007
ASCA-CHEK
K071711 · NBT
Techlab Inc., Corporate Research Center
Immunology · 138d
Cleared Nov 07, 2007
KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
K072135 · NWG
Kronus Market Development Associates,...
Immunology · 97d
Cleared Nov 07, 2007
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL &...
K072423 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 70d
Cleared Nov 07, 2007
UNICRYL QUICK
K072644 · GAM
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 50d
Cleared Nov 07, 2007
UNIGLACTIN
K072645 · GAM
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 50d
Cleared Nov 07, 2007
UNICAPRONE
K072646 · GAM
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 50d
Cleared Nov 07, 2007
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
K072956 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 19d
Cleared Nov 07, 2007
ROYALE AE 9036 LSP INJECTOR
K073010 · MSS
Asico, LLC
Ophthalmic · 13d
Cleared Nov 06, 2007
AUSCO ES-3100
K070550 · DQD
Koratek Company, Ltd.
Cardiovascular · 252d
Cleared Nov 06, 2007
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · BTR
C.R. Bard, Inc.
Anesthesiology · 175d