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
75673–75696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2002
COSMED QUARK C12/QUARK T12
K014262 · DPS
Cosmed Srl
Cardiovascular · 89d
Cleared Mar 26, 2002
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
K014303 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Mar 26, 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K020479 · DQA
Datex-Ohmeda
Anesthesiology · 41d
Cleared Mar 26, 2002
CARD IQ ANALYSIS II
K020796 · JAK
GE Medical Systems
Radiology · 14d
Cleared Mar 26, 2002
I-FLOW ELASTOMERIC PUMP
K020862 · MEB
I-Flow Corp.
General Hospital · 8d
Cleared Mar 25, 2002
3M ATTEST 290 AUTO-READER
K004009 · FRC
3M Company
General Hospital · 454d
Cleared Mar 25, 2002
JOE LUBE CONDOM
K011363 · HIS
Marketing Sales Concepts, Inc. (Msci)
Obstetrics & Gynecology · 326d
Cleared Mar 25, 2002
JOE LUB HELMET CONDOM
K011378 · HIS
Marketing Sales Concepts, Inc. (Msci)
Obstetrics & Gynecology · 326d
Cleared Mar 25, 2002
ZOLL PAD
K011388 · MKJ
Zoll Medical Corp
Cardiovascular · 322d
Cleared Mar 25, 2002
UNICEM
K020256 · EMA
3M Espe AG Dental Products
Dental · 60d
Cleared Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Mar 23, 2002
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
K020596 · JIT
Diamond Diagnostics, Inc.
Chemistry · 29d
Cleared Mar 22, 2002
PRONTO
K014240 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 86d
Cleared Mar 22, 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037 · JWY
Dade Microscan, Inc.
Microbiology · 77d
Cleared Mar 22, 2002
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K020580 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915 · MHX
Ge Medical Systems Information...
Cardiovascular · 203d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139 · CGA
Roche Diagnostics Corp.
Chemistry · 94d
Cleared Mar 21, 2002
ODI TALON INTRAMEDULLARY HIP NAIL
K014189 · JDS
Orthopedic Designs, Inc.
Orthopedic · 90d
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 21, 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · GEI
Aesculap, Inc.
General & Plastic Surgery · 90d
Cleared Mar 21, 2002
SECCA SYSTEM
K014216 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 21, 2002
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
K014248 · KNA
Urogyn , Ltd.
Obstetrics & Gynecology · 85d
Cleared Mar 21, 2002
PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
K020001 · INI
Transworld Mobility Distribution, LLC
Physical Medicine · 78d