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
146665–146688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1985
SCEPTOR ENTERIC MIC PANEL
K854102 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR ENTERIC MIC/ID PANEL
K854103 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
OXYCOIL
K854239 · BYX
Chad Therapeutics, Inc.
Anesthesiology · 24d
Cleared Nov 13, 1985
ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP
K850792 · FRN
Janssen Pharmaceutica, Inc.
General Hospital · 260d
Cleared Nov 13, 1985
SURGILASE 40S
K852470 · GEX
Surgilase, Inc.
General & Plastic Surgery · 155d
Cleared Nov 13, 1985
R.R. PRONTO SIRINGA
K852503 · FMF
Medical Hospital Equipment
General Hospital · 154d
Cleared Nov 13, 1985
CENTERCOM CONTROL
K853270 · FNL
Carrom Healthcare, Inc.
General Hospital · 100d
Cleared Nov 13, 1985
LINEAR ARRAY PROBE PLB-310M FOR SAL-32B
K853311 · IYO
Toshiba Medical Systems
Radiology · 98d
Cleared Nov 13, 1985
MORGAN SUTURE-DRILL
K853376 · HWE
Bowen & Company, Inc.
Orthopedic · 93d
Cleared Nov 13, 1985
SANA-LUBE
K853653 · KMJ
Huntington Laboratories, Inc.
General Hospital · 71d
Cleared Nov 13, 1985
THE DEXTRA PRECISION POWER UNIT
K853778 · GEY
Storz Instrument Co.
General & Plastic Surgery · 65d
Cleared Nov 13, 1985
STATLOCK
K854008 · LHI
Healthtek, Inc.
General Hospital · 44d
Cleared Nov 13, 1985
MIDAS REX OPERATING ROOM VISE
K854123
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 35d
Cleared Nov 13, 1985
SURGICAL & DENTAL INSTRUMENT
K854146 · GEN
Baort, Inc.
General & Plastic Surgery · 33d
Cleared Nov 13, 1985
MECRON UNCEMENTED STRUCTURED STEM HIP
K854191
Mecron Medical Products, Inc.
Orthopedic · 93d
Cleared Nov 13, 1985
ANADIAS NASAL SAW BLADES
K854192 · GFA
Anadias, Inc.
General & Plastic Surgery · 29d
Cleared Nov 13, 1985
NEEDLE W/STYLET FOR IMPLANTATION
K854238 · GAA
Microvasive
General & Plastic Surgery · 23d
Cleared Nov 13, 1985
SETMA FHT, MODEL ST 8130
K854263 · ILJ
Setma, Inc.
Physical Medicine · 21d
Cleared Nov 13, 1985
CAMBRIDGE MODEL XT1000
K854283 · IOL
Cambridge Medical Instruments, Inc.
Physical Medicine · 20d
Cleared Nov 13, 1985
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
K854327 · GCB
Concord Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Nov 13, 1985
AQUACEL SURGICAL PREP PADS
K854344 · FRO
Advanced Ortho-Technology, Inc.
General & Plastic Surgery · 15d
Cleared Nov 12, 1985
HOTIP HEMOSTATIC PROBE
K843628 · LNK
Trimedyne, Inc.
Gastroenterology & Urology · 424d
Cleared Nov 12, 1985
MODEL J25-25 WATT CO2 LASER
K851425 · HHR
Britt Corp., Inc.
Obstetrics & Gynecology · 216d
Cleared Nov 12, 1985
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
K852790 · CHL
Nova Biomedical Corp.
Hematology · 134d