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
123289–123312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1991
GAMMA 600 NUCLEAR MEDICINE COMPUTER
K903469 · IYX
Strichman Medical Equipment, Inc.
Radiology · 187d
Cleared Feb 04, 1991
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
K903639 · GEX
Nidek, Inc.
General & Plastic Surgery · 175d
Cleared Feb 04, 1991
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
K903731 · GWF
Teca, Inc.
Neurology · 172d
Cleared Feb 04, 1991
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · BTR
Boston Medical Products, Inc.
Anesthesiology · 166d
Cleared Feb 04, 1991
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
K903941 · IZI
Shimadzu Medical Systems
Radiology · 161d
Cleared Feb 04, 1991
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · LBZ
Syva Co.
Toxicology · 90d
Cleared Feb 04, 1991
CONTORNO(R), MODELS E AND ST
K905108 · GEI
Palex Intl. SA
General & Plastic Surgery · 83d
Cleared Feb 04, 1991
OLYMPUS URINE PH
K905146 · JQY
Diagnostic Systems
Chemistry · 81d
Cleared Feb 04, 1991
STS(TM) FLUOROSCOPIC IMAGING MODULE
K905278 · JAA
Medstone Intl., Inc.
Radiology · 73d
Cleared Feb 04, 1991
BIOTROL BILIRUBIN C & T CONTROL
K905280 · JJX
Biotrol, USA, Inc.
Chemistry · 73d
Cleared Feb 04, 1991
OPUS T3 TEST SYSTEM
K905410 · CDP
Pb Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Feb 04, 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Feb 04, 1991
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
K905814 · CGJ
London Diagnostics, Inc.
Chemistry · 38d
Cleared Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Feb 04, 1991
ELECTRAPETTE (R)
K910140 · JQW
Matrix Technologies Corp.
Chemistry · 21d
Cleared Feb 04, 1991
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K910143 · JIY
Eastman Kodak Company
Chemistry · 21d
Cleared Feb 04, 1991
CIBA CORNING ACS LH IMMUNOASSAY
K910198 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 19d
Cleared Feb 01, 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · DQY
Cook, Inc.
Cardiovascular · 207d
Cleared Feb 01, 1991
MICREL LTD PORTABLE INFUSION MICROPUMP
K903571 · FRN
Technology Transfer Intl., Inc.
General Hospital · 177d
Cleared Feb 01, 1991
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
K904095 · GQL
California Integrated Diagnostics, Inc.
Microbiology · 148d
Cleared Feb 01, 1991
SEXTON CYSTOTOMY URINE PUMP (SCUP2)
K904434 · KOB
Phoenix Bioengineering, Inc.
Gastroenterology & Urology · 126d
Cleared Feb 01, 1991
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
K904491 · DQO
Lifestream Int'L, Inc.
Cardiovascular · 122d
Cleared Feb 01, 1991
MODEL 5866-37M LEAD ADAPTOR KIT
K904575 · DTD
Medtronic Vascular
Cardiovascular · 115d