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
134713–134736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1988
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · CKG
Nichols Institute Diagnostics
Chemistry · 60d
Cleared Aug 30, 1988
FIAGEN HGH FLUOROIMMUNOASSAY KIT
K882823 · CFL
Cyberfluor, Inc.
Chemistry · 53d
Cleared Aug 30, 1988
DTR ANALYZER
K882913 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
VISTA INSTRUMENT
K882914 · JJE
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
METHENO-STAIN KIT
K883052 · JTS
Scientific Device Laboratory, Inc.
Pathology · 42d
Cleared Aug 30, 1988
DART CARBON DIOXIDE
K883055 · KHS
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Aug 30, 1988
WAKO(TM) AUTOKIT AMYLASE
K883059 · CJA
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Aug 30, 1988
FLOSSIE
K883225 · JET
Richard G. Deniro
Dental · 29d
Cleared Aug 30, 1988
SYNTHETIC CAST TAPE
K883294 · LGF
Carapace, Inc.
Orthopedic · 26d
Cleared Aug 30, 1988
MODEL #918 MULTI-PADS
K883375 · DRO
Cardiotronics, Inc.
Cardiovascular · 21d
Cleared Aug 30, 1988
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191
K883451 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 29, 1988
VITALOGRAPH-ALPHA
K873562 · BZG
Vitalograph , Ltd.
Anesthesiology · 362d
Cleared Aug 29, 1988
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
K881013 · IYX
Toshiba Medical Systems
Radiology · 172d
Cleared Aug 29, 1988
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
K881015 · JHI
Pacific Biotech, Inc.
Chemistry · 172d
Cleared Aug 29, 1988
INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
K881836 · KWS
Intermedics Orthopedics
Orthopedic · 119d
Cleared Aug 29, 1988
TEKNAR PERCU-SCAN
K881850 · IYO
Teknar, Inc.
Radiology · 119d
Cleared Aug 29, 1988
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD
K881868 · DPM
Supelco, Inc.
Toxicology · 118d
Cleared Aug 29, 1988
BIOPRO PC FEMORAL HIP COMPONENT
K882146 · JDI
Biopro, Inc.
Orthopedic · 98d
Cleared Aug 29, 1988
SERIES I AND II IMPLANTS
K882226 · DZE
Saber Technology, Inc.
Dental · 95d
Cleared Aug 29, 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · LDJ
Syva Co.
Toxicology · 87d
Cleared Aug 29, 1988
ELIMINATOR AIR FILTER
K882468 · KDQ
Apex Medical, Inc.
General Hospital · 75d
Cleared Aug 29, 1988
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593 · DPW
Cardio Metrics, Inc.
Cardiovascular · 66d
Cleared Aug 29, 1988
LAD MODEL 633 LUMINOMETER
K882608 · JJQ
Los Alamos Diagnostics
Chemistry · 66d
Cleared Aug 29, 1988
PHARMACIA CHLAMYDIA EIA
K882676 · LJC
Pharmacia, Inc.
Microbiology · 62d