FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139225–139248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1987
PREDICTOR
K871436 · DQK
Corazonix Corp.
Cardiovascular · 67d
Cleared Jun 19, 1987
MORGAN THERAPEUTIC LENS
K871454 · KYG
Mortan, Inc.
Ophthalmic · 67d
Cleared Jun 19, 1987
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
K871605 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 56d
Cleared Jun 19, 1987
PMT TRACTION TONGS
K871663 · HAX
Progress Mankind Technology
Neurology · 52d
Cleared Jun 19, 1987
EASY READ(TM)
K871794 · DXN
Health O Meter
Cardiovascular · 43d
Cleared Jun 19, 1987
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
K871827 · KXJ
General Electric Co.
Radiology · 39d
Cleared Jun 19, 1987
BT-795/ATS
K871847 · CAC
Electromedics, Inc.
Anesthesiology · 38d
Cleared Jun 19, 1987
CANON SURGICAL AUTO KERATOMETER SK-1
K871936 · HLQ
Canon USA, Inc.
Ophthalmic · 32d
Cleared Jun 19, 1987
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
K872063 · JHY
Hybritech, Inc.
Chemistry · 22d
Cleared Jun 19, 1987
UMSC HOLTER MONITORING KIT
K872087 · DSH
United Medical Supply Co., Inc.
Cardiovascular · 18d
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