FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80833–80856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 24, 2000
CYTOPLAST SUTURE
K003028 · NBY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 57d
Cleared Nov 24, 2000
IMAGE VASCULAR LASER
K003046 · GEX
Sciton, Inc
General & Plastic Surgery · 56d
Cleared Nov 24, 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · MNH
Osteotech, Inc.
Orthopedic · 24d
Cleared Nov 24, 2000
ALUMINA V40 HEAD
K003413 · LZO
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 24, 2000
ISS OFFSET HEADS
K003428 · HSD
Biomet, Inc.
Orthopedic · 21d
Cleared Nov 22, 2000
PC ECG 1200
K000404 · MWI
Norav Medical , Ltd.
Cardiovascular · 289d
Cleared Nov 22, 2000
ALPHA OMEGA DUAL COOLER-HEATER
K001520 · DWC
Alpha Omega, Inc.
Cardiovascular · 190d
Cleared Nov 22, 2000
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
K001563 · FGO
Scion Cardiovascular, Inc.
Gastroenterology & Urology · 187d