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
89353–89376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1998
MYCYCLE, HANDMASTER, VICTORY
K981557 · IOR
Richvale , Ltd.
Physical Medicine · 69d
Cleared Jul 09, 1998
MYCYCLE HANDMASTER, LIGHT
K981558 · IOR
Richvale , Ltd.
Physical Medicine · 69d
Cleared Jul 09, 1998
MONARCH IOL DELIVERY SYSTEM
K981571 · KYB
Alcon Laboratories
Ophthalmic · 66d
Cleared Jul 09, 1998
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
K981579 · MDM
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Jul 09, 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL,...
K981706 · JIX
Abbott Laboratories
Chemistry · 56d
Cleared Jul 09, 1998
SILIMED MALAR IMPLANT
K981835 · LZK
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Jul 09, 1998
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
K981837 · ITI
Motion Concepts
Physical Medicine · 44d
Cleared Jul 09, 1998
SILIMED CHIN IMPLANTS
K981850 · FWP
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Jul 09, 1998
SILIMED SILICONE CARVING BLOCK
K981851 · MIB
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Jul 09, 1998
DEGANIA SILICONE IDENTI LOOPS
K981956 · DXC
Degania Silicone , Ltd.
Cardiovascular · 35d
Cleared Jul 09, 1998
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES,...
K982032 · MEH
Osteonics Corp.
Orthopedic · 29d
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · LJC
Dade Behring, Inc.
Microbiology · 16d
Cleared Jul 09, 1998
VIGIL PROTEIN CONTROL
K982224 · JJY
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jul 08, 1998
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
K974698 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 204d
Cleared Jul 08, 1998
SKINTONER SYSTEM
K980501 · GEX
Fuller Research Corp.
General & Plastic Surgery · 149d
Cleared Jul 08, 1998
ODYSSEY INSTRUMENTATION SYSTEM
K981294 · FIZ
Automata Instrumentation, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 08, 1998
SPEED-CUT AUTOMATIC BIOPSY SYSTEM
K981301 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 90d
Cleared Jul 08, 1998
EBI DFS JOINT FIXATOR, MODEL 02800
K981483 · KTT
Electro-Biology, Inc.
Orthopedic · 75d
Cleared Jul 08, 1998
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY...
K981612 · EZL
Rochester Medical Corp.
Gastroenterology & Urology · 63d
Cleared Jul 08, 1998
KSEA UROPUMP
K981615 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 07, 1998
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
K972255 · LOS
Pulse Biomedical, Inc.
Cardiovascular · 385d
Cleared Jul 07, 1998
PERCUTANEOUS BREAST BIOPSY (PBB)
K972328 · KNW
Urothealth System, Inc.
Gastroenterology & Urology · 379d
Cleared Jul 07, 1998
CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
K972899 · DXQ
Cypress Medical Products, Ltd.
Cardiovascular · 335d
Cleared Jul 07, 1998
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · JPA
International Technidyne Corp.
Hematology · 197d