FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89689–89712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1998
CT SCOPE
K974344 · JAK
Elscint, Inc.
Radiology · 196d
Cleared Jun 03, 1998
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 196d
Cleared Jun 03, 1998
SHELHIGH NO-REACT PERICARDIAL PATCHES
K974914 · DXZ
Shelhigh, Inc.
Cardiovascular · 177d
Cleared Jun 03, 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
K980850 · DSP
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jun 03, 1998
JPACS
K980918 · LMD
Philips Medical Systems (Cleveland),...
Radiology · 84d
Cleared Jun 03, 1998
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K981609 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 29d
Cleared Jun 03, 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND...
K981687 · JXM
Phamatech
Toxicology · 21d
Cleared Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
K981722 · LCX
Quidel Corp.
Chemistry · 19d
Cleared Jun 02, 1998
CS/3(TM) MONITORS*
K974792 · DSI
Datex-Engstrom, Inc.
Cardiovascular · 162d
Cleared Jun 02, 1998
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
K980829 · CAF
Steripak, Ltd.
Anesthesiology · 90d
Cleared Jun 02, 1998
REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM
K980838 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 02, 1998
EXETER INTRAMEDULLARY BONE PLUG
K980843 · JDI
Howmedica, Inc.
Orthopedic · 90d
Cleared Jun 02, 1998
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
K981014 · MID
Zeus Scientific, Inc.
Immunology · 76d
Cleared Jun 02, 1998
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
K981021 · MID
Zeus Scientific, Inc.
Immunology · 75d
Cleared Jun 01, 1998
EAGLE CENTURY STEAM STERILIZER
K964332 · FLE
Amsco Intl., Inc.
General Hospital · 579d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
K971006 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
K971007 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
FOCUS RTP SYSTEM
K973936 · IYE
Computerized Medical Systems, Inc.
Radiology · 229d
Cleared Jun 01, 1998
ICON IMPLANT SYSTEM
K974106 · DZE
Bio Science Technologies, Inc.
Dental · 213d
Cleared Jun 01, 1998
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
K974812 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 160d
Cleared Jun 01, 1998
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
K980100 · MSR
Storz Instrument Co.
Ophthalmic · 140d
Cleared Jun 01, 1998
EQUIDOSE SOLID STATE DIODE DETECTORS
K980826 · IYE
Cii Mastek, Inc.
Radiology · 90d
Cleared Jun 01, 1998
SNORE-CURE ANTI-SNORING APPLIANCE
K980952 · LRK
Ortho-Tain, Inc.
Dental · 80d
Cleared Jun 01, 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
K981062 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 70d