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
87289–87312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 28, 1999
RDI DIRECT LDL CHOLESTEROL TEST
K984107 · MRR
Reference Diagnostics, Inc.
Chemistry · 72d
Cleared Jan 28, 1999
MS400
K984113 · IPF
Lsi Intl., Inc.
Physical Medicine · 72d
Cleared Jan 28, 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132 · DCK
Diagnostic Products Corp.
Immunology · 71d
Cleared Jan 28, 1999
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
K984137 · MVM
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Jan 28, 1999
P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
K984158 · JWH
Depuy, Inc.
Orthopedic · 70d
Cleared Jan 28, 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · LBR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 57d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · HWC
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Jan 28, 1999
MECHANICAL WHEELCHAIR
K984354 · IOR
Colours 'N Motion
Physical Medicine · 55d
Cleared Jan 28, 1999
ACTIVX
K984367 · IOR
Adorno Rogers Technology
Physical Medicine · 52d
Cleared Jan 28, 1999
BIRCOLL BALLOON DISSECTOR
K984448 · FZW
Wells Johnson Co.
General & Plastic Surgery · 45d
Cleared Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Jan 28, 1999
HEMOCHEK SAMPLE COLLECTION KIT
K984529 · LCP
Osborn Laboratories, Inc.
Hematology · 38d
Cleared Jan 28, 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · MNI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jan 28, 1999
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
K990161 · JJY
Bio-Rad
Chemistry · 9d
Cleared Jan 28, 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
K990162 · JJX
Bio-Rad
Chemistry · 9d