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
144649–144672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 02, 1986
R1361 & R1372 MEASURED EXERCISE EQUIPMENT
K861348 · ISD
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213
K861350 · INW
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
R1698,R1701,R1215,R1700 & R860 POWERED TABLES
K861352 · INQ
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
PAP SMEAR KIT
K861389 · HHT
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 18d
Cleared May 02, 1986
HANDHELD DYNAMOMETER, MODEL #160 AND #111
K861396 · HRW
Spark Instruments & Academics, Inc.
Neurology · 17d
Cleared May 02, 1986
SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
K861460 · LJK
Widran Urological Group, Ltd.
Microbiology · 14d
Cleared May 02, 1986
#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
K861470 · HAX
Applied Medical Systems
Neurology · 10d
Cleared May 02, 1986
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
K861474 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 10d
Cleared May 02, 1986
HEARING AID (ALL IN THE EAR)
K861492 · ESD
Crystal Tone Hearing Instruments
Ear, Nose, Throat · 10d
Cleared May 02, 1986
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540 · CAE
Dryden Corp.
Anesthesiology · 8d