FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86761–86784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1999
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
K984055 · FOZ
Sims Deltec, Inc.
General Hospital · 77d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
K984152 · DJG
Beckman Coulter, Inc.
Toxicology · 71d
Cleared Jan 29, 1999
DCI ENDOSCOPE
K984369 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 53d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · JIF
Beckman Coulter, Inc.
Chemistry · 51d
Cleared Jan 29, 1999
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
K984477 · JJY
Bio-Rad
Chemistry · 44d
Cleared Jan 29, 1999
EXHALATION VALVE
K984481 · CBP
Intersurgical, Inc.
Anesthesiology · 44d
Cleared Jan 29, 1999
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
K984626 · JJX
Bio-Rad
Chemistry · 32d
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC...
K990026 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 24d
Cleared Jan 29, 1999
AVL OMNI MODULAR ANALYZER
K990092 · CHL
Avl Scientific Corp.
Chemistry · 18d
Cleared Jan 29, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
K990125 · DSI
Hewlett-Packard GmbH
Cardiovascular · 16d
Cleared Jan 28, 1999
ASKINA HYDROCOLLOID/THIN
K973227 · KMF
B.Braun Medical, Inc.
General & Plastic Surgery · 519d
Cleared Jan 28, 1999
PHILIPS EASYGUIDE
K981480 · HAW
Philips Medical Systems, Inc.
Neurology · 279d
Cleared Jan 28, 1999
CD HORIZON SPINAL SYSTEM
K981676 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 261d
Cleared Jan 28, 1999
IS-RUBELLA IGG TEST SYSTEM
K981729 · LFX
Diamedix Corp.
Microbiology · 258d
Cleared Jan 28, 1999
COMPEED PSORIASIS DRESSING
K982493 · FRO
Coloplast Corp.
General & Plastic Surgery · 195d
Cleared Jan 28, 1999
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · KTN
Oxoid , Ltd.
Immunology · 184d
Cleared Jan 28, 1999
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K983560 · MBI
Innovasive Devices, Inc.
Orthopedic · 107d
Cleared Jan 28, 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · HWC
Sulzer Orthopedics, Inc.
Orthopedic · 107d
Cleared Jan 28, 1999
AUTOSTAT II ANA SCREEN ELISA
K983655 · LJM
Cogent Diagnotics , Ltd.
Immunology · 101d
Cleared Jan 28, 1999
UALB
K983774 · JIR
Abbott Laboratories
Chemistry · 94d
Cleared Jan 28, 1999
CAPELLA COCHLEAR EMISSIONS ANALYZER
K983851 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 28, 1999
BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429
K983852 · GEI
Geiger Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jan 28, 1999
MS300
K984021 · IPF
Lsi Intl., Inc.
Physical Medicine · 77d
Cleared Jan 28, 1999
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
K984082 · MGQ
Emox 911 CC
General & Plastic Surgery · 73d