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
70225–70248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2003
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
K032802 · QPB
Hk Surgical, Inc.
General & Plastic Surgery · 71d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869 · DQY
Cook, Inc.
Cardiovascular · 65d
Cleared Nov 19, 2003
INTERLAB IMMUNOFIXATION TEST(S)
K033187 · CFF
Interlab S.R.L.
Immunology · 49d
Cleared Nov 19, 2003
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
K033188 · MMX
Idev Technologies, Inc.
Cardiovascular · 49d
Cleared Nov 19, 2003
SCOUT PRO
K033320 · DQY
Biotronik, Inc.
Cardiovascular · 35d
Cleared Nov 19, 2003
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · KPR
Analogic Corp.
Radiology · 30d
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · JDK
Implex Corp.
Orthopedic · 27d
Cleared Nov 19, 2003
SPEEDLYSER INFUSION CATHETER KIT
K033443 · QEY
AngioDynamics, Inc.
Cardiovascular · 21d
Cleared Nov 19, 2003
GE PRECISION MPI
K033486 · OWB
Nrt-Nordisk Rontgen Teknik A/S
Radiology · 15d
Cleared Nov 18, 2003
DELTA SHOULDER
K021478 · PHX
Depuy, Inc.
Orthopedic · 559d
Cleared Nov 18, 2003
MARINA MEDICAL SILICONE PESSARY
K031463 · HHW
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 194d
Cleared Nov 18, 2003
PARADIGMPAL, MODEL MMT-7330
K031541 · LZG
Minimed, Inc.
General Hospital · 186d
Cleared Nov 18, 2003
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND...
K031553 · BTO
Arcadia Medical Corporation
Anesthesiology · 183d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · HRS
Arthrex, Inc.
Orthopedic · 173d
Cleared Nov 18, 2003
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · MHI
Remel, Inc.
Microbiology · 147d
Cleared Nov 18, 2003
GLUCOSE TOLERANCE BEVERAGE
K032753 · MRV
Perk Scientific, Inc.
Chemistry · 74d
Cleared Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 71d
Cleared Nov 18, 2003
PASCO MIC AND MIC/ID PANELS
K033119 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · FPA
Becton, Dickinson & CO
General Hospital · 29d
Cleared Nov 18, 2003
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · LJT
Horizon Medical Products, Inc.
General Hospital · 15d
Cleared Nov 17, 2003
STONE EXTRACTOR BALLOON CATHETER
K011261 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 936d
Cleared Nov 17, 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · GEX
Laserscope
General & Plastic Surgery · 332d
Cleared Nov 17, 2003
GYRUS OPEN FORCEPS
K024286 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 329d
Cleared Nov 17, 2003
ARTELON SURGICAL SUTURE
K032160 · GAR
Artimplant AB
General & Plastic Surgery · 125d