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
113785–113808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1993
CEPTI-SEAL I.V. PREP KIT
K930196 · LRS
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 169d
Cleared Jul 02, 1993
INTELECT 222 P
K930307 · IMI
Chattanooga Group, Inc.
Physical Medicine · 162d
Cleared Jul 02, 1993
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · IKN
Bio-Logic Systems Corp.
Neurology · 161d
Cleared Jul 02, 1993
PHYACTION 787
K930670 · IPF
Verimed Holdings, Inc.
Physical Medicine · 143d
Cleared Jul 02, 1993
SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
K930895 · JOH
Mallinckrodt Medical Tpi, Inc.
Anesthesiology · 130d
Cleared Jul 02, 1993
ZEFON GAS SAMPLING LINES
K930957 · CCK
Zefon Medical Products
Anesthesiology · 129d
Cleared Jul 02, 1993
SEIDEL HUMERAL LOCKING NAIL
K931256 · HSB
Howmedica Corp.
Orthopedic · 112d
Cleared Jul 02, 1993
IN THE CANAL AID OTOSONIC ACS II WITH SRR
K931881 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 79d
Cleared Jul 02, 1993
BELTONE OPTIMA 2000 ITE HEARING AID
K932058 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 65d
Cleared Jul 02, 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932190 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
BREATHING BAGS
K932191 · BTC
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
PEDIATRIC ANESTHESIA CIRCUITS
K932192 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932193 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
PEDIATRIC GASSAMPLING CIRCUITS
K932194 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
ADULT GAS SAMPLING CIRCUITS
K932195 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
COAXIAL CIRCUITS
K932196 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 02, 1993
CUSTOM ANESTHESIA CIRCUITS
K932197 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 01, 1993
VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS
K914162 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 653d
Cleared Jul 01, 1993
VAS-CATH DUALATOR(TM) VESSEL DILATOR
K914210 · FKA
Vas-Cath, Inc.
Gastroenterology & Urology · 651d
Cleared Jul 01, 1993
FRESENIUS PD+ EXCHANGE DEVICE
K915634 · EKX
Fresenius USA, Inc.
Dental · 562d
Cleared Jul 01, 1993
CRITIKON VITAL SIGNS MODULE
K915697 · DXN
Critikon Company, LLC
Cardiovascular · 556d
Cleared Jul 01, 1993
BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
K921048 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 484d
Cleared Jul 01, 1993
SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR
K923595 · DXN
Advanced Medical Instruments, Inc.
Cardiovascular · 346d
Cleared Jul 01, 1993
EL2-SERIES BLOOD COLLECTION REERVOIR
K930154 · DTN
Electromedics, Inc.
Cardiovascular · 169d