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
137473–137496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1988
TORQUE HEX WRENCH
K875147 · DTF
Cardiac Pacemakers, Inc.
Cardiovascular · 43d
Cleared Jan 27, 1988
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
K875162 · HHT
Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared Jan 27, 1988
BITEK(TM) BLOOD CULTURE SYSTEM
K875259 · JSG
Definitive Diagnostics, Inc.
Microbiology · 36d
Cleared Jan 27, 1988
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
K875275 · JTQ
Sterling Drug, Inc.
Microbiology · 34d
Cleared Jan 27, 1988
MODEL UCA / SPEC SYSTEM UCA
K875305 · FZH
Spec Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jan 27, 1988
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
K875321 · IOQ
Kinetic Concepts, Inc.
Physical Medicine · 29d
Cleared Jan 27, 1988
BREWER GEL FOR ANAEROBES
K875362 · KZJ
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 27d
Cleared Jan 27, 1988
GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
K880083 · FJI
Gambro, Inc.
Gastroenterology & Urology · 15d
Cleared Jan 26, 1988
OPACITY LENSMETER 701
K874355 · HKI
Intraoptics, Inc.
Ophthalmic · 95d
Cleared Jan 26, 1988
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · JDG
Richards Medical Co., Inc.
Orthopedic · 60d
Cleared Jan 26, 1988
GOOD LOOKS DAZZLERS
K875067 · HQY
Mel Appel
Ophthalmic · 48d
Cleared Jan 22, 1988
WATER-JEL(R) BURN DRESSING
K864841 · FRO
Trilling Resources, Ltd.
General & Plastic Surgery · 409d
Cleared Jan 22, 1988
LSP AUTOMATIC VENTILATOR, MODEL 456
K870424 · BTL
Life Support Products, Inc.
Anesthesiology · 353d
Cleared Jan 22, 1988
MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
K871421 · IPF
Futuremed Div. of Future Impex Corp.
Physical Medicine · 288d
Cleared Jan 22, 1988
MODEL 5050 SURGILASER FOR PULMONARY USE
K871876 · LLO
Lasermatic, Inc.
Anesthesiology · 253d
Cleared Jan 22, 1988
MODEL 5050 SURGILASER FOR NEUROSURGERY USE
K871933 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 248d
Cleared Jan 22, 1988
AMASTIM 2000
K872704 · GZJ
Amatech International, Inc.
Neurology · 199d
Cleared Jan 22, 1988
AMOX OXYGEN GENERATORS
K873156 · CAW
Vbm Corp.
Anesthesiology · 175d
Cleared Jan 22, 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · CBK
Puritan Bennett Corp.
Anesthesiology · 168d
Cleared Jan 22, 1988
CBG CUFF MANOMETER
K873614 · BSK
Bio-Med Devices, Inc.
Anesthesiology · 136d
Cleared Jan 22, 1988
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY
K873790 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 126d
Cleared Jan 22, 1988
MODIFIED STRESS MACHINE
K873819 · ISA
S.J.F., Inc.
Physical Medicine · 123d
Cleared Jan 22, 1988
INTERFERENTIAL CURRENT UNIT
K874119 · LIH
Compustim Electronics
Neurology · 100d
Cleared Jan 22, 1988
BIO-COR II COLLAGEN CORNEAL SHIELD
K874224 · MOE
Bausch & Lomb, Inc.
Ophthalmic · 98d