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
76177–76200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2002
ACCESS SEQUESTRATION SYSTEM
K012406 · CAC
Interpore Cross Intl.
Anesthesiology · 239d
Cleared Mar 26, 2002
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
K012852 · KYF
Optonol, Ltd.
Ophthalmic · 214d
Cleared Mar 26, 2002
MOONRAY MOBILE C-ARM
K013426 · OXO
Simad S.R.L.
Radiology · 161d
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · MRG
DiaSorin, Inc.
Chemistry · 110d
Cleared Mar 26, 2002
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES
K014236 · GEX
Clinicon Corp.
General & Plastic Surgery · 90d
Cleared Mar 26, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL...
K014243 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Mar 26, 2002
NTERO HOTROD SYSTEM
K014251 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2002
DERMACHILLER 4
K014253 · GEX
Paradigm Trex, LLC
General & Plastic Surgery · 90d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 90d
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