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
83353–83376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2000
SOCON SPINAL SYSTEM
K993551 · MNH
Aesculap, Inc.
Orthopedic · 86d
Cleared Jan 13, 2000
ACUMED SUTURE ANCHOR
K993657 · MBI
Acu Med, Inc.
Orthopedic · 77d
Cleared Jan 13, 2000
SIGMA MANUAL WHEELCHAIR
K993963 · IOR
Sigma Distribution & Supply, Inc.
Physical Medicine · 52d
Cleared Jan 13, 2000
PORTABLE LIGHT CURING UNIT
K994048 · EBZ
Gregory S. Jacob, D.D.S.
Dental · 48d
Cleared Jan 13, 2000
AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
K994072 · ITI
Amylior, Inc.
Physical Medicine · 42d
Cleared Jan 13, 2000
AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL...
K994107 · ITI
Amylior, Inc.
Physical Medicine · 38d
Cleared Jan 13, 2000
MANUAL WHEELCHAIR
K994185 · IOR
Major Mobility Products, Inc.
Physical Medicine · 34d
Cleared Jan 13, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
K994208 · DTM
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Jan 13, 2000
TRX-CG POWER TILT AND RECLINE SYSTEM
K994241 · ITI
Motion Concepts
Physical Medicine · 29d
Cleared Jan 13, 2000
MODIFICATION TO BONE ANCHOR AND KIT (BAK)
K994313 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jan 13, 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · DQX
Cordis Corp.
Cardiovascular · 17d
Cleared Jan 12, 2000
HANNAH WIRELESS VITAL SIGNS MONITOR
K991087 · FLS
Ilife Systems, Inc.
Anesthesiology · 287d
Cleared Jan 12, 2000
SIEMEMNS INFINITY ETC02 POD
K992116 · CCK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 204d
Cleared Jan 12, 2000
HOT SHOT FLUID WARMER IV FLUIDS
K992258 · LDQ
Infra-Med Technologies, Inc.
General & Plastic Surgery · 190d
Cleared Jan 12, 2000
BIORCI SCREW
K992396 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 177d
Cleared Jan 12, 2000
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
K992719 · KNT
Amsino Intl., Inc.
Gastroenterology & Urology · 153d
Cleared Jan 12, 2000
LEMAITRE BILIARY CATHETER
K992941 · LQR
Vascutech, Inc.
Gastroenterology & Urology · 134d
Cleared Jan 12, 2000
SEGMENTED VAGINAL APPLICATOR
K993472 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Jan 12, 2000
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING...
K993567 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 83d
Cleared Jan 12, 2000
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
K993793 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 64d
Cleared Jan 12, 2000
CONVERTORS SURGICAL DRAPES
K993795 · KKX
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Jan 12, 2000
ENA PROFILE ELISA TEST SYSTEM
K993839 · LLL
Trinity Biotech USA
Immunology · 61d
Cleared Jan 12, 2000
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION...
K993859 · LYZ
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 58d
Cleared Jan 12, 2000
SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION...
K993880 · LYZ
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 58d