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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
120961–120984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1991
NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
K904499 · KFG
Ackrad Laboratories
Microbiology · 273d
Cleared Jul 01, 1991
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · CAI
Vital Signs, Inc.
Anesthesiology · 208d
Cleared Jul 01, 1991
FUTURA FEMORAL HIP STEM
K910093 · JDI
O'Tec Corp.
Orthopedic · 174d
Cleared Jul 01, 1991
QUALTEX ISLAND DRESSING
K910657 · KGX
Deroyal Industries, Inc.
General & Plastic Surgery · 137d
Cleared Jul 01, 1991
SHARPS PIN CUSHION(TM) CONTAINER
K911436 · FMI
Catalyst, Inc.
General Hospital · 90d
Cleared Jul 01, 1991
TRAPEZOIDAL MALAR IMPLANT
K911513 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
ARTICULATED CHIN IMPLANT
K911514 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
EXTENDED MALAR IMPLANT
K911515 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
HIGH PROFILE CHIN IMPLANT
K911516 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
MG II POROUS COBAL T-CHROME FEMORAL COMPONENT
K911572 · JWH
Zimmer, Inc.
Orthopedic · 84d
Cleared Jul 01, 1991
OMNIFIT II EPF HIP STEM SERIES
K911585 · MEH
Osteonics Corp.
Orthopedic · 83d
Cleared Jul 01, 1991
MONOPOLAR POLLYPECTOMY SNARE
K911700 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 76d
Cleared Jul 01, 1991
ARD(TM) ANTIMICROBIAL REMOVAL DEVICE
K911771 · LJK
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Jul 01, 1991
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
K911801 · JIN
Gds Technology, LLC
Chemistry · 69d
Cleared Jul 01, 1991
OPUS(R) TOBRAMYCIN
K911940 · LCR
Pb Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Jul 01, 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · DIH
Eastman Kodak Company
Chemistry · 42d
Cleared Jul 01, 1991
KETO-340 II
K912373 · JIN
Ihara Medics U.S., Inc.
Chemistry · 33d
Cleared Jul 01, 1991
I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
K912387 · JGS
I-Stat Corp.
Chemistry · 61d
Cleared Jul 01, 1991
CHEM-LINK DATA BASE MANAGER
K912413 · JJQ
Technicon Instruments Corp.
Chemistry · 31d
Cleared Jul 01, 1991
AMYLASE REAGENT
K912519 · JFJ
Genzyme Corp.
Chemistry · 25d
Cleared Jul 01, 1991
IMX HCG
K912534 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
IMX TOTAL B-HCG
K912535 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
K912559 · JGS
Nova Biomedical Corp.
Chemistry · 20d
Cleared Jun 28, 1991
LYME DISEASE IGM ELISA
K900206 · LSR
Hillcrest Biologicals
Microbiology · 528d