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
139825–139848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1987
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
K872136 · HJK
Ocular Instruments, Inc.
Ophthalmic · 16d
Cleared Jun 19, 1987
OPHTHALMIC CANNULA
K872151 · HMX
Pharmacia, Inc.
Ophthalmic · 15d
Cleared Jun 19, 1987
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
K872245 · IXC
General Electric Co.
Radiology · 8d
Cleared Jun 18, 1987
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
K864610 · LLF
Inframed, Inc.
Neurology · 210d
Cleared Jun 18, 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · KPR
General Electric Co.
Radiology · 136d
Cleared Jun 18, 1987
DOTOLO COLON HYDROTHERAPY INSTRUMENT
K870534 · KPL
Dotolo Research Corp. C/O Keller and...
Gastroenterology & Urology · 129d
Cleared Jun 18, 1987
NEUROTIPS(TM)
K871571 · GXB
Ulster Scientific, Inc.
Neurology · 57d
Cleared Jun 18, 1987
GEM-CRIT CHECK
K871686 · DRY
Diamond Sensor Systems
Cardiovascular · 50d
Cleared Jun 18, 1987
FLEXIBLE BIOPSY FORCEP
K871809 · OCZ
Surgi-Aid Endoscopics, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 18, 1987
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
K872078 · DER
Solomon Park Research Laboratories
Immunology · 20d
Cleared Jun 18, 1987
D-SCOPE II AND D-SCOPE IIC
K872127 · IYX
Medx, Inc.
Radiology · 16d
Cleared Jun 17, 1987
E.W.L. P-TENS/H-WAVE
K862121 · KZM
Electronic Waveform Laboratory, Inc.
Dental · 379d
Cleared Jun 17, 1987
LYFO KWIK(TM) RUS KIT
K870731 · JXA
Micro-Bio-Logics
Microbiology · 112d
Cleared Jun 17, 1987
ACCULEVEL CARBAMAZEPINE TEST
K871254 · KLT
Syva Co.
Toxicology · 79d
Cleared Jun 17, 1987
DELFIA(TM) THYROXINE (T4) KIT
K871303 · CDX
Lkb Instruments, Inc.
Chemistry · 77d
Cleared Jun 17, 1987
ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
K871449 · KPE
Pa Medical Corp.
General Hospital · 65d
Cleared Jun 17, 1987
LINER OR GSRI-PNF
K871497 · EBI
Gulf South Research Institute
Dental · 62d
Cleared Jun 17, 1987
SAFESIDE(TM) LUMED
K871546 · FOZ
Luther Medical Products, Inc.
General Hospital · 58d
Cleared Jun 17, 1987
THEOPHYLLINE FPIA CONTROLS
K871589 · LAW
Sigma Chemical Co.
Toxicology · 54d
Cleared Jun 17, 1987
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
K871620 · GTZ
Allelix, Inc.
Microbiology · 51d
Cleared Jun 17, 1987
NEO-I TEMPERATURE & CONDUCTIVITY METER
K871708 · FIZ
Automata, Inc.
Gastroenterology & Urology · 47d
Cleared Jun 17, 1987
ADULT PERM-CATH 40CM.
K871749 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 17, 1987
VAN-TEC REUSABLE HELICAL STONE BASKET
K871777 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 42d
Cleared Jun 17, 1987
HELICAL STONE BASKET (DISPOSABLE)
K871779 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 42d