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
144049–144072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1986
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K860940 · ETF
Micromedics, Inc.
Ear, Nose, Throat · 51d
Cleared May 02, 1986
DIRECTACLONE CG SLIDE PREGNANCY TEST
K860945 · JHJ
Pacific Biotech, Inc.
Chemistry · 51d
Cleared May 02, 1986
SCM-400 HOLTER SYSTEM
K860950 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared May 02, 1986
ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM
K860981 · GCY
Sun Technologies
General & Plastic Surgery · 49d
Cleared May 02, 1986
SCLEROTHERAPY INJECTION CATHETER
K860991 · KNT
Endovations
Gastroenterology & Urology · 46d
Cleared May 02, 1986
VOX COMPANION
K860992 · ESE
Bloomfield Research and Development,...
Ear, Nose, Throat · 46d
Cleared May 02, 1986
GASTROINTESTINAL CYTOLOGY BRUSH
K860997 · FDX
Endovations
Gastroenterology & Urology · 45d
Cleared May 02, 1986
MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
K861046 · LNK
Sharplan Industries, Inc.
Gastroenterology & Urology · 45d
Cleared May 02, 1986
ORTHOJOIN, ORTHODONTIC ADHESIVE
K861118 · DYH
Ortho Source
Dental · 38d
Cleared May 02, 1986
PROGRAMALITH III PULSE GENERATOR
K861140 · DXY
Pacesetter Systems
Cardiovascular · 37d
Cleared May 02, 1986
EMIT DESIPRAMINE ASSAY
K861155 · LFG
Syva Co.
Toxicology · 35d
Cleared May 02, 1986
OSTEOMILL BONE GRINDER
K861164 · LYS
Biodynamic Technologies, Inc.
Orthopedic · 35d
Cleared May 02, 1986
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
K861240 · DSI
Mountain View Medical
Cardiovascular · 30d
Cleared May 02, 1986
PEDABAROGRAPH
K861260 · JFC
Biokinetics, Inc.
Physical Medicine · 29d
Cleared May 02, 1986
DISPOSABLE NEEDLE COUNTER
K861307 · MMK
Anago, Inc.
General Hospital · 24d
Cleared May 02, 1986
ACCUPAC CUSTOM PACK KERLIX SQUARES
K861308 · EFQ
Geneva Laboratories, Inc.
General & Plastic Surgery · 24d
Cleared May 02, 1986
DISPOSABLE NEEDLE COUNTER (20-240)
K861316 · MMK
Anago, Inc.
General Hospital · 24d
Cleared May 02, 1986
DISPOSABLE NEEDLE COUNTER (20-530)
K861317 · MMK
Anago, Inc.
General Hospital · 24d
Cleared May 02, 1986
DISPOSABLE NEEDLE COUNTER (20-720)
K861318 · FMI
Anago, Inc.
General Hospital · 24d
Cleared May 02, 1986
DISPOSABLE NEEDLE COUNTER (20-560)
K861319 · MMK
Anago, Inc.
General Hospital · 24d
Cleared May 02, 1986
CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE
K861334 · HNN
Cilco, Inc.
Ophthalmic · 23d
Cleared May 02, 1986
R1750 AND R1424 POWERED HEATING UNITS
K861340 · IRQ
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
R1363 PARAFFIN
K861346 · IMC
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
R1596 POWERED EXERCISE EQUIPMENT
K861347 · IOL
Tri W-G, Inc.
Physical Medicine · 25d