FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
127969–127992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 30, 1990
SILICONE PLUG
K896678 · HRX
Orthopedic Systems, Inc.
Orthopedic · 64d
Cleared Jan 30, 1990
VITRO T4-EIA-XT
K896865 · KLI
In Vitro Diagnostics, Inc.
Chemistry · 55d
Cleared Jan 30, 1990
MODIFIED ASSESS(R) PEAK FLOW METER
K896953 · BZH
Health Products, Inc.
Anesthesiology · 56d
Cleared Jan 30, 1990
NOVELTY GRADUATION SUNGLASSES
K900046 · HQY
Gibson Greetings, Inc.
Ophthalmic · 27d
Cleared Jan 30, 1990
KESTREL LENS CASE 731H-893S/P-1700-2611
K900053 · LRX
Kestrel
Ophthalmic · 27d
Cleared Jan 30, 1990
KESTREL LENS CASE 1543-893S/P-1700-2611
K900054 · LRX
Kestrel
Ophthalmic · 27d
Cleared Jan 29, 1990
8400ST VOLUME VENTILATOR
K894322 · CBK
Bird Products Corp.
Anesthesiology · 199d
Cleared Jan 29, 1990
GENESIS III, (MOD. 7003/7004)
K894370 · DXK
Biosound, Inc.
Cardiovascular · 199d
Cleared Jan 29, 1990
PASCO MIC/ID GRAM-POSITIVE PANEL
K895215 · JWY
Difco Laboratories, Inc.
Microbiology · 164d
Cleared Jan 29, 1990
CLEARVIEW CHLAMYDIA
K895280 · LJC
Unipath , Ltd.
Microbiology · 158d