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
149161–149184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1985
ESCOTEK-EST 301A ULTRA-SONIC UNIT
K844386 · IMI
Nor-Am Patient Care Products, Inc.
Physical Medicine · 169d
Cleared May 01, 1985
SURGICRAFT COPELAND DISPOSABLE
K844608 · HGP
A.W. Showell (Surgicraft) , Ltd.
Obstetrics & Gynecology · 155d
Cleared May 01, 1985
FETAL TELEMETRY SYSTEM
K844724 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 148d
Cleared May 01, 1985
ABDOMINAL PRESSURE CONTROL VALVE
K844829 · HHR
L.A.S.E.R., Inc.
Obstetrics & Gynecology · 140d
Cleared May 01, 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · DTC
Cordis Corp.
Cardiovascular · 128d
Cleared May 01, 1985
SUN MEDICAL LAMINARIA CERVICAL DILATOR
K845006 · HDY
Sun Medical, Inc.
Obstetrics & Gynecology · 126d
Cleared May 01, 1985
DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
K850255
Dow Corning Corp. Healthcare...
Orthopedic · 99d
Cleared May 01, 1985
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
K850332 · BXB
Richards Medical Co., Inc.
Physical Medicine · 93d
Cleared May 01, 1985
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
K850361 · FFT
Synectics-Dantec
Gastroenterology & Urology · 91d
Cleared May 01, 1985
HI-LO TILT TABLE 625
K850377 · INQ
Tri W-G, Inc.
Physical Medicine · 91d
Cleared May 01, 1985
KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES
K850631 · JDQ
Kirschner Medical Corp.
Orthopedic · 71d
Cleared May 01, 1985
ZIMMER THREADED ACETABULAR CUP
K850766 · KWA
Zimmer, Inc.
Orthopedic · 65d
Cleared May 01, 1985
DRESSING CHANGE KIT
K850887 · FOZ
Creative Care Systems, Inc.
General Hospital · 58d
Cleared May 01, 1985
GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK
K850957 · JTN
Warner-Lambert Co.
Microbiology · 54d
Cleared May 01, 1985
PREGNA-ZYME
K850992 · JHI
Armkel, LLC
Chemistry · 51d
Cleared May 01, 1985
I.V. START KIT
K851226
Perry, Div.
General & Plastic Surgery · 36d
Cleared May 01, 1985
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
K851263 · HLI
American Medical Optics
Ophthalmic · 34d
Cleared May 01, 1985
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
K851264 · HLI
American Medical Optics
Ophthalmic · 34d
Cleared May 01, 1985
ABCO ISOLATION MASKS
K851312
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared May 01, 1985
ABCO SUTURE REMOVAL KITS-METAL & PLASTIC FORCEPS
K851313
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared May 01, 1985
ABCO DRAPES/TOWELS
K851314 · KKX
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 01, 1985
ABCO INSTRUMENT PACKS & TRAYS
K851315 · FRG
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 01, 1985
EMIT 700 CANNABINOID 20 ASSAY
K851373 · LDJ
Syva Co.
Toxicology · 23d
Cleared May 01, 1985
76 EMA LINING CEMENT
K851468 · EMA
G-C Intl. Corp.
Dental · 15d