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
83113–83136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2000
DOGBONE ACFS
K994383 · KWQ
Theken Surgical
Orthopedic · 38d
Cleared Feb 04, 2000
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K994438 · MQM
Spectrx, Inc.
Chemistry · 36d
Cleared Feb 03, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K000020 · MNH
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 03, 2000
EBI XFIX DFS RAIL SYSTEM
K000083 · KTT
Ebi, L.P.
Orthopedic · 22d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · HWC
Synthes (Usa)
Orthopedic · 22d
Cleared Feb 03, 2000
PRO-TORQ
K000120 · EBW
Micro Motors, Inc.
Dental · 16d
Cleared Feb 03, 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 14d
Cleared Feb 03, 2000
TED 200T7 OXYGEN MONITOR
K990403 · CCL
Teledyne Electronic Technologies
Anesthesiology · 359d
Cleared Feb 03, 2000
SD-730 IF-SDS, PERFECT PULSE IF-SDS
K992652 · LIH
Skylark Device & Systems Co., Ltd.
Neurology · 181d
Cleared Feb 03, 2000
T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424,...
K992804 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 168d
Cleared Feb 03, 2000
E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER
K992828 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 164d
Cleared Feb 03, 2000
VERSALET 7700 CARE CENTER, MODEL # 7700
K993051 · FMZ
Hill-Rom Air-Shields
General Hospital · 143d
Cleared Feb 03, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS...
K993383 · DSI
Hewlett-Packard GmbH
Cardiovascular · 118d
Cleared Feb 03, 2000
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
K993745 · MKJ
Katecho, Inc.
Cardiovascular · 90d
Cleared Feb 03, 2000
CD HORIZON SPINAL SYSTEM
K993810 · MNH
Danek Medical, Inc.
Orthopedic · 85d
Cleared Feb 03, 2000
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR...
K994006 · GJS
Avocet Medical, Inc.
Hematology · 71d
Cleared Feb 03, 2000
EXTENDED STRAIGHT ATTACHMENT
K994024 · EGS
Team Technologies, Inc.
Dental · 69d
Cleared Feb 03, 2000
GLORY
K994127 · INI
Pillar Technology, Inc.
Physical Medicine · 58d
Cleared Feb 03, 2000
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
K994136 · LYZ
Shanghai Champion Plastic Products...
General Hospital · 58d
Cleared Feb 03, 2000
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
K994168 · JIS
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 03, 2000
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
K994169 · JIS
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 03, 2000
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · JHI
Advantage Diagnostics Corp.
Chemistry · 50d
Cleared Feb 03, 2000
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
K994256 · GCJ
A & A Medical, Inc.
General & Plastic Surgery · 48d
Cleared Feb 03, 2000
ARABESK TOP
K994268 · EBF
Voco GmbH
Dental · 48d