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
70825–70848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 06, 2003
CARDIOQ, MODEL 9051-7005
K031706 · DPW
Deltex Medical
Cardiovascular · 65d
Cleared Aug 06, 2003
CADSTREAM
K031779 · LLZ
Confirma, Inc.
Radiology · 57d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · DKB
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
K031943 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Aug 06, 2003
TRI-LOOP MICROWAVE ABLATION PROBE
K032047 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 35d
Cleared Aug 06, 2003
BENCO ADMIX
K032152 · EJJ
Southern Dental Industries, Inc.
Dental · 70d
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · IYN
Medison America, Inc.
Radiology · 8d
Cleared Aug 05, 2003
DIGITAL TEMPERATURE MONITOR
K030219 · FLL
Kang Ying Medical Appliances, Inc.
General Hospital · 195d
Cleared Aug 05, 2003
LIFESYNE SYSTEMS
K030795 · DRG
Gmp/Companies, Inc.
Cardiovascular · 146d
Cleared Aug 05, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
K031282 · LJT
LeMaitre Vascular, Inc.
General Hospital · 105d
Cleared Aug 05, 2003
CARRIER TIPS
K031461 · ELC
Dentsply Intl.
Dental · 89d
Cleared Aug 05, 2003
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
K031717 · CDZ
Roche Diagnostics Corp.
Chemistry · 63d
Cleared Aug 05, 2003
COLTOSOL F
K031752 · EMA
Coltene/Whaledent, Inc.
Dental · 61d
Cleared Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
K031775 · DKB
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Aug 05, 2003
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786 · EOX
Vision-Sciences, Inc.
Ear, Nose, Throat · 56d
Cleared Aug 05, 2003
SAFEPRO PLUS SAFETY SYRINGE
K031830 · MEG
Formosa Medical Devices, Inc.
General Hospital · 53d
Cleared Aug 05, 2003
PULPDENT ETCH-RITE ROYALE
K031915 · KLE
Pulpdent Corporation
Dental · 46d
Cleared Aug 05, 2003
TINA-QUANT CRP (LATEX)
K032336 · DCN
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
K032346 · MSX
Ge Medical Systems Information...
Cardiovascular · 6d
Cleared Aug 04, 2003
GLUCOLEADER VALUE
K023279 · NBW
Hmd Biomedical, Inc.
Chemistry · 307d
Cleared Aug 04, 2003
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
K023548 · DQY
Velocimed
Cardiovascular · 286d