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

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175,820 results
130561–130584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1989
PACER R 9 TREADMILL
K893032 · IOL
Pacer Industries, Inc.
Physical Medicine · 94d
Cleared Jul 27, 1989
KIT, INTRAVENOUS EXTENSION TUBING
K893120 · FPA
Island Medical
General Hospital · 93d
Cleared Jul 27, 1989
MULTI-GAS ANALYZER (MGA)
K893589 · CCK
Marquette Gas Analysis Corp.
Anesthesiology · 79d
Cleared Jul 27, 1989
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684 · CGN
Ciba Corning Diagnostics Corp.
Chemistry · 72d
Cleared Jul 27, 1989
CHARISE CHARLES REAGENT BLOOD STRIPS
K893894 · JIO
Lee Import Domestic Consulting
Hematology · 58d
Cleared Jul 27, 1989
ELECTRA 1000C AUTOMATIC COAGULATION TIMER
K894052 · GKP
Medical Laboratory Automation...
Hematology · 50d
Cleared Jul 27, 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · DXH
Medtronic Vascular
Cardiovascular · 44d
Cleared Jul 27, 1989
ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR
K894345 · IOR
Damaco
Physical Medicine · 13d
Cleared Jul 27, 1989
OPMILAS CO2-L
K894393 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 10d
Cleared Jul 25, 1989
PHYNE-VU
K885096 · FRO
Medical Resources, Ltd.
General & Plastic Surgery · 228d
Cleared Jul 25, 1989
LYME DISEASE MICROASSAY
K890843 · LSR
Diamedix Corp.
Microbiology · 154d
Cleared Jul 25, 1989
SIEMENS CEILING STAND 800F, 800 AND 810
K891023 · LDQ
Siemens Medical Electronics
General & Plastic Surgery · 147d
Cleared Jul 25, 1989
BODY COOLER OR COOLVEST OR ALPHA BODY COOLER
K891603 · ILO
Alpha Rehabilitation Products
Physical Medicine · 127d
Cleared Jul 25, 1989
GENETIC SYSTEMS MICROPLATE READER
K891767 · JJQ
Genetic Systems Corp.
Chemistry · 123d
Cleared Jul 25, 1989
THE FERN CRYOPROBE
K892237 · GEH
Cryogenic Instruments & Equipment , Ltd.
General & Plastic Surgery · 112d
Cleared Jul 25, 1989
INJECTION PORT FOR---INTERMITTENT INJECTION
K892429 · FPA
The Medi-Dose Group
General Hospital · 106d
Cleared Jul 25, 1989
SONGER WIRING SYSTEM
K892651 · LRN
Danek Medical, Inc.
Orthopedic · 103d
Cleared Jul 25, 1989
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 96d
Cleared Jul 25, 1989
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
K893128 · CDL
Stanbio Laboratory
Chemistry · 91d
Cleared Jul 25, 1989
CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD
K893454 · KLC
Atlantic Industries, Inc.
Dental · 83d
Cleared Jul 25, 1989
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · LKQ
Immuno Concepts, Inc.
Microbiology · 83d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · LJC
Abbott Laboratories
Microbiology · 70d
Cleared Jul 25, 1989
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K893775 · JQW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 64d
Cleared Jul 25, 1989
M.F.S. LOW AIR LOSS PULSATING BED
K893801 · IOQ
Medical Flotation Systems, Inc.
Physical Medicine · 64d