Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70825–70848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2003
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
K033057 · FYA
Deroyal
General Hospital · 52d
Cleared Nov 20, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
K033237 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 45d
Cleared Nov 20, 2003
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K033401 · BWF
Advanced Circulatory Systems, Inc.
Anesthesiology · 27d
Cleared Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · KPS
Cti Pet Systems, Inc.
Radiology · 23d
Cleared Nov 20, 2003
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
K033438 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 23d
Cleared Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · JIX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · JAK
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 20, 2003
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
K033593 · NLU
Clearmedical, Inc.
Gastroenterology & Urology · 7d
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