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
83857–83880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · DXC
Aesculap, Inc.
Cardiovascular · 209d
Cleared Jan 13, 2000
ITP, MODEL 1.0
K992434 · MUJ
Nucletron Corp.
Radiology · 176d
Cleared Jan 13, 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · JOW
Aircast, Inc.
Cardiovascular · 174d
Cleared Jan 13, 2000
PE 501 PC-ECG MONITOR
K992584 · MWJ
Nhe Corp.
Cardiovascular · 164d
Cleared Jan 13, 2000
NIPRO LUER ADAPTOR
K992729 · FMI
Nipro Medical Corp.
General Hospital · 153d
Cleared Jan 13, 2000
A-2000 BATHING SYSTEMS
K992779 · ILJ
Medi-Man Rehabilitation Products, Inc.
Physical Medicine · 148d
Cleared Jan 13, 2000
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
K993377 · NAQ
Polymer Technology Systems, Inc.
Chemistry · 107d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · DSI
Datascope Corp.
Cardiovascular · 87d
Cleared Jan 13, 2000
AVIVA SYSTEM, MODEL SL1010
K993550 · DRG
American Telecare, Inc.
Cardiovascular · 85d
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