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
142945–142968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · DXT
C.R. Bard, Inc.
Cardiovascular · 42d
Cleared Sep 23, 1986
MEDSENTRY FLOTATION SYSTEM
K863152 · FNM
Medsentry Corp.
General Hospital · 39d
Cleared Sep 23, 1986
TENZCARE SNAP ELECTRODE, NO. 6865
K863307 · GXY
3M Company
Neurology · 29d
Cleared Sep 23, 1986
GRAF CORELLO, POWERED WHEELCHAIR
K863407 · ITI
Graf Products, Inc.
Physical Medicine · 20d
Cleared Sep 23, 1986
ANGIOMED HIGH PRESSURE CONNECTORS
K863446 · GCD
Angiomed U.S., Inc.
General & Plastic Surgery · 15d
Cleared Sep 23, 1986
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
K863480 · DTB
Biotronik Sales, Inc.
Cardiovascular · 14d
Cleared Sep 23, 1986
MEDIFLEX TRANSDUCER PROTECTOR
K863496 · FIB
Mediflex Intl.
Gastroenterology & Urology · 14d
Cleared Sep 23, 1986
URESIL THORACIC VENT
K863561 · KDQ
Uresil Corp.
General Hospital · 11d
Cleared Sep 22, 1986
STEERABLE CATHETER SYSTEM
K862424 · GCP
Endovations
Gastroenterology & Urology · 88d
Cleared Sep 22, 1986
TWIN-CORE
K863031 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 42d
Cleared Sep 22, 1986
ULS 8-86
K863163 · DYN
American Instrument Manufacturer'S, Inc.
Dental · 35d
Cleared Sep 22, 1986
I.V. START KIT
K863284
Welmed Systems, Inc.
General & Plastic Surgery · 28d
Cleared Sep 22, 1986
ESTILUX(R) POSTERIOR C
K863314 · EBF
Kulzer, Inc.
Dental · 27d
Cleared Sep 22, 1986
MULTIFIL(R) VS
K863315 · EBF
Kulzer, Inc.
Dental · 27d
Cleared Sep 22, 1986
STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
K863500 · EIS
Pacific Union Dental, Inc.
Dental · 13d
Cleared Sep 19, 1986
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD
K862053 · DTB
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD
K862054 · DTB
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF
K862151 · IYO
Hewlett-Packard Co.
Radiology · 107d
Cleared Sep 19, 1986
NOZEES NOSTRIL DILATOR
K862406 · LWF
Nozees Co.
Ear, Nose, Throat · 86d
Cleared Sep 19, 1986
PANAGRAF
K862829 · KLE
Panadent International, Inc.
Dental · 56d
Cleared Sep 19, 1986
MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY
K862862 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 52d
Cleared Sep 19, 1986
APNET RESPIRATION MONITOR
K862962 · BZQ
Wireless Monitors, Inc.
Anesthesiology · 44d
Cleared Sep 19, 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · DQX
Target Therapeutics
Cardiovascular · 43d
Cleared Sep 19, 1986
DENTAL COMPOSITE RESTORATIVE
K863092 · EBF
Dentsply Intl.
Dental · 37d