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
75793–75816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · JWY
Dade Microscan, Inc.
Microbiology · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · JWY
Dade Behring, Inc.
Microbiology · 35d
Cleared May 03, 2002
PSYCHEMEDICS RIA CANNABINOID ASSAY
K011426 · LAT
Psychemedics Corp.
Toxicology · 360d
Cleared May 03, 2002
INDWELLING FECAL MANAGEMENT SYSTEM
K012113 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 301d
Cleared May 03, 2002
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
K012800 · HRY
Whiteside Biomechanics, Inc.
Orthopedic · 255d
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 144d
Cleared May 03, 2002
SANIDAD HEALTH-UP TENS MP-73725
K014126 · GZJ
Roc Chinese-European Industrial...
Neurology · 137d
Cleared May 03, 2002
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230...
K020354 · GXD
Baylis Medical Co., Inc.
Neurology · 88d
Cleared May 03, 2002
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
K020365 · KRI
3t Medical Systems, LLC
Cardiovascular · 88d
Cleared May 03, 2002
OCULIGHT SL/SLX
K020374 · HQF
Iridex Corp
Ophthalmic · 88d
Cleared May 03, 2002
THE NURTURE III BREAST PUMP
K020375 · HGX
Bailey Medical Engineering
Obstetrics & Gynecology · 88d
Cleared May 03, 2002
MASTER & FRANK SURGICAL DRAPES (STERILE)
K020393 · KKX
Master & Frank Enterprses Co., Ltd.
General Hospital · 86d
Cleared May 03, 2002
MEDION 6000
K020476 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 80d
Cleared May 03, 2002
SMOKE EVACUATION HOSES/TUBING
K020510 · FYD
Dm Medical, Inc.
General Hospital · 77d
Cleared May 03, 2002
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 72d
Cleared May 03, 2002
STARFLOW HV
K020760 · EBF
Danville Materials, Inc.
Dental · 57d
Cleared May 03, 2002
PULMO-MIST COMPRESSOR MODEL # 4323
K020797 · BTI
Nidek Medical Products, Inc.
Anesthesiology · 52d
Cleared May 03, 2002
ECHOSCAN, MODEL US-1800
K020876 · IYO
Nidek, Inc.
Radiology · 46d
Cleared May 03, 2002
GC ELITE CEMENT 100
K021038 · EMA
GC America, Inc.
Dental · 32d
Cleared May 03, 2002
EBI XFIX DFS SYSTEM
K021091 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared May 03, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared May 03, 2002
ESOP HA FEMORAL STEM
K021108 · MEH
Fournitures Hospitalieres
Orthopedic · 28d
Cleared May 03, 2002
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION...
K021216 · FPA
Sterling Medivations, Inc.
General Hospital · 16d
Cleared May 03, 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
K021244 · DZE
Ace Surgical Supply Co., Inc.
Dental · 14d