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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81433–81456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391 · LZO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Nov 28, 2000
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
K003473 · IZH
Elscintec Systems , Ltd.
Radiology · 20d
Cleared Nov 27, 2000
SOFTSENS
K001521 · GXY
Integrated Biosensing Technologies
Neurology · 195d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
K002263 · LDJ
Branan Medical Corp.
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
K002264 · DIO
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
K002265 · DJC
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
K002268 · DJG
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
K002342 · JXM
Branan Medical Corporation
Toxicology · 118d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · JJY
Dade Behring, Inc.
Chemistry · 75d
Cleared Nov 27, 2000
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069 · MID
Quest Intl., Inc.
Immunology · 56d
Cleared Nov 27, 2000
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · CJE
Diagnostic Chemicals , Ltd.
Chemistry · 55d
Cleared Nov 27, 2000
COLOSCREEN-ES
K003359 · KHE
Helena Laboratories
Hematology · 31d
Cleared Nov 27, 2000
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · JZO
Pharmacia & Upjohn Co.
Immunology · 25d
Cleared Nov 27, 2000
SYNCHRON CONTROL
K003488 · JJY
Beckman Coulter, Inc.
Toxicology · 14d
Cleared Nov 24, 2000
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · HCG
Cook, Inc.
Neurology · 270d
Cleared Nov 24, 2000
SCAN LT40 (40 CHANNELS)
K001564 · OLT
Neuro Scan Labs
Neurology · 189d
Cleared Nov 24, 2000
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K001692 · JXE
Neurosoft, Inc.
Neurology · 175d
Cleared Nov 24, 2000
SALUMEDICA NERVE CUFF
K002098 · JXI
Salumedica, LLC
Neurology · 136d
Cleared Nov 24, 2000
COD COMPRESSION OSTEOTOMY DEVICE
K002184 · HRS
Walter Abendschein, M.D.
Orthopedic · 128d
Cleared Nov 24, 2000
ONCOLOGY SALVAGE SYSTEM
K002757 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Nov 24, 2000
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
K002764 · HRX
Hydrocision, Inc.
Orthopedic · 80d
Cleared Nov 24, 2000
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC...
K002765 · GWM
Integra Neurosciences
Neurology · 80d
Cleared Nov 24, 2000
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 70d
Cleared Nov 24, 2000
METRX SYSTEM
K002931 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 65d