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
142345–142368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1986
CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON
K852547 · DQO
Cortronic Corp.
Cardiovascular · 514d
Cleared Nov 10, 1986
BOVIE ULTRASONIC SURGICAL SYSTEM
K855138 · LBK
Clinical Technology Corp.
Neurology · 322d
Cleared Nov 10, 1986
ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
K860467 · QGH
Medcraft Corp.
Neurology · 277d
Cleared Nov 10, 1986
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX
K862613 · LQF
Gen-Probe, Inc.
Microbiology · 124d
Cleared Nov 10, 1986
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX
K862614 · LQF
Gen-Probe, Inc.
Microbiology · 124d
Cleared Nov 10, 1986
HIGH VELOCITY CW DOPPLER SYSTEM
K862841 · DPW
Biosound, Inc.
Cardiovascular · 104d
Cleared Nov 10, 1986
3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306
K863041 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 1986
3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305
K863043 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 1986
5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307
K863096 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1986
OPTEC 1000 DMV
K863509 · HOX
Stereo Optical Co., Inc.
Ophthalmic · 62d
Cleared Nov 10, 1986
PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
K863625 · LGQ
Windsor Laboratories, Inc.
Toxicology · 54d
Cleared Nov 10, 1986
CHARTER LABORATORIES INC. LENS LUBRICANT
K863974 · HPX
Paco Pharmaceutical Services, Inc.
Ophthalmic · 27d
Cleared Nov 10, 1986
EXETER OPERATING LOUPE
K863983 · HJH
Exeter Instruments, Inc.
Ophthalmic · 27d
Cleared Nov 10, 1986
C-IOO MOBILE CINE CT UNIT
K864046 · JAK
Imatron, Inc.
Radiology · 25d
Cleared Nov 10, 1986
TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
K864161 · BTR
Toob-Cheq, Inc.
Anesthesiology · 18d
Cleared Nov 07, 1986
NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER
K855177 · DXN
Philips Park
Cardiovascular · 316d
Cleared Nov 07, 1986
DECITEL AUSCULSCOPE
K860994 · DQD
Bloomfield Research and Development,...
Cardiovascular · 235d
Cleared Nov 07, 1986
BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE
K861435 · CAW
The John Bunn Co.
Anesthesiology · 204d
Cleared Nov 07, 1986
SCHEIN AP-1 AIR POLISHING UNIT
K862384 · KOJ
Henry Schein, Inc.
Dental · 136d
Cleared Nov 07, 1986
ECG MODULE
K862553 · DPS
Elscint, Inc.
Cardiovascular · 127d
Cleared Nov 07, 1986
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
K862919 · KFZ
Transpirator Technologics, Inc.
Anesthesiology · 98d
Cleared Nov 07, 1986
COOK-VPI INTERMITTENT CATHETER
K863082 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 07, 1986
BIOCHEM CO/OX 1000
K863186 · DQA
Biochem International, Inc.
Anesthesiology · 80d
Cleared Nov 07, 1986
VENT-PLANT DENTAL IMPLANT, OSSEOLOCK AND ROBUTMENT
K863755 · DZE
Vent-Plant Corporation, Inc.
Dental · 43d