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
145513–145536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1986
MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
K854887 · EMH
Walter Lorenz Surgical, Inc.
Dental · 84d
Cleared Feb 28, 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · DFT
Kallestad Laboratories, Inc.
Immunology · 74d
Cleared Feb 28, 1986
COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
K855022 · BSZ
Computerized Anesthesia Systems, Inc.
Anesthesiology · 74d
Cleared Feb 28, 1986
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
K855065 · FPB
Cobe Laboratories, Inc.
General Hospital · 72d
Cleared Feb 28, 1986
DELFIA TM HLH KIT
K855173 · CEP
Lkb Instruments, Inc.
Chemistry · 64d
Cleared Feb 28, 1986
STIMUPLEX, NERVE STIMULATOR
K860126 · BXN
Burron Medical Products, Inc.
Anesthesiology · 45d
Cleared Feb 28, 1986
CARBON DIOXIDE ABSORBENTS
K860147 · CBL
Dentsply Intl.
Anesthesiology · 44d
Cleared Feb 28, 1986
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
K860228 · CFL
Boots-Celltech Diagnostics, Inc.
Chemistry · 37d
Cleared Feb 28, 1986
DUPONT PHENOBARBITAL CALIBRATOR
K860303 · LFN
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Feb 28, 1986
DUPONT PHENOBARBITAL ASSAY
K860304 · LFN
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Feb 28, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · CFH
Sterling Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 28, 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530 · CJA
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Feb 27, 1986
KALMATE MODEL 3A
K854476 · GZJ
Medical Technology Systems, Inc.
Neurology · 112d
Cleared Feb 27, 1986
BIO-FIT HIP SYSTEM
K854791 · KWL
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Feb 27, 1986
CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)
K854969 · IYO
Cilco, Inc.
Radiology · 78d
Cleared Feb 27, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170 · HKI
Canon USA, Inc.
Ophthalmic · 63d
Cleared Feb 27, 1986
AIR/FLUID EXCHANGE SYSTEM
K855215 · FRN
Mira, Inc.
General Hospital · 59d
Cleared Feb 27, 1986
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · KWY
Howmedica Corp.
Orthopedic · 59d
Cleared Feb 27, 1986
DIGILAB CAMBRIDGE PERIMETER
K860115 · HOO
Bio-Rad
Ophthalmic · 45d
Cleared Feb 27, 1986
OPERATING ROOM TRAY
K860160 · FSM
Medical Design Concepts, Inc.
General & Plastic Surgery · 42d
Cleared Feb 27, 1986
MAZING HEAT DISPOSABLE WARM PACK
K860444 · IMD
Leebryan Intl.
Physical Medicine · 23d
Cleared Feb 27, 1986
G.A.S./GRIESHABER AIR SYSTEM
K860502 · FRN
Grieshaber & Co.
General Hospital · 16d
Cleared Feb 26, 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · DQY
Cook, Inc.
Cardiovascular · 365d
Cleared Feb 26, 1986
SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR
K852421 · DXN
Nbs Medical, Inc.
Cardiovascular · 264d