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
127369–127392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1990
CARBON DIOXIDE REAGENT
K896590 · KHS
Pointe Scientific, Inc.,
Chemistry · 72d
Cleared Feb 01, 1990
AUTO-CUFF(TM)
K896633 · DXN
U.S. Medical Corp.
Cardiovascular · 71d
Cleared Feb 01, 1990
VACCON
K896733 · KGX
Unoplast A/S
General & Plastic Surgery · 63d
Cleared Feb 01, 1990
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846 · KIR
Baxter Healthcare Corp
Pathology · 58d
Cleared Feb 01, 1990
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST
K896859 · MBT
Gen-Probe, Inc.
Microbiology · 58d
Cleared Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 43d
Cleared Feb 01, 1990
NARKOMED 2B ANESTHESIA SYSTEM
K900328 · BSZ
Draeger Medical, Inc.
Anesthesiology · 9d
Cleared Feb 01, 1990
NARKOMED 3 ANESTHESIA SYSTEM
K900329 · BSZ
Draeger Medical, Inc.
Anesthesiology · 9d
Cleared Jan 31, 1990
AWC BUTTERFLY WOUND CLOSURES
K894802 · FPX
American White Cross, Inc.
General & Plastic Surgery · 187d
Cleared Jan 31, 1990
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 181d
Cleared Jan 31, 1990
TITANIUM MODULAR COLLARED HIP PROSTHESIS
K895035 · JDI
Depuy, Inc.
Orthopedic · 175d
Cleared Jan 31, 1990
TITANIUM MODULAR MODULAR COLLARLESS HIP
K895036 · JDI
Depuy, Inc.
Orthopedic · 175d
Cleared Jan 31, 1990
ANGIOSCOPY PUMP
K895074 · DQI
Baxter Healthcare Corp
General Hospital · 170d
Cleared Jan 31, 1990
DENTAL BRIDGE ANCHORING PINS
K896337 · EGG
Gayso Bridge-Tech, Inc.
Dental · 89d
Cleared Jan 31, 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414 · DTN
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Jan 31, 1990
TRANSPARENT FILM I.V. SITE/WOUND DRESSING
K896421 · KMK
Catalina Biomedical Corp.
General & Plastic Surgery · 84d
Cleared Jan 31, 1990
PEDIATRIC DRAIN BAG
K896581 · FFH
Laytech Medical Co.
Gastroenterology & Urology · 75d
Cleared Jan 31, 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609 · IZH
Philips Medical Systems North...
Radiology · 175d
Cleared Jan 31, 1990
ARTERIOVENOUS FISTULA SETS
K900125 · FIE
Baxter Healthcare Corp
Gastroenterology & Urology · 22d
Cleared Jan 31, 1990
NKA MODELS AB-601G AND AB-621G
K900272 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d
Cleared Jan 30, 1990
PORGES ERCP CATHETERS
K896503 · FGE
Porges Corp.
Gastroenterology & Urology · 76d
Cleared Jan 30, 1990
PORGES UNIVERSAL HANDLES
K896505 · GCP
Porges Corp.
Gastroenterology & Urology · 76d
Cleared Jan 30, 1990
HSC UNIT ROD
K896603 · KWP
Danek Medical, Inc.
Orthopedic · 70d
Cleared Jan 30, 1990
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
K896642 · CEP
Medix Biotech, Inc.
Chemistry · 67d