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
86305–86328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1999
BONE MULCH SCREW SYSTEM
K991298 · HWC
Biomet, Inc.
Orthopedic · 29d
Cleared May 14, 1999
PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)
K991404 · FMI
Itl Corporation Pty, Ltd.
General Hospital · 22d
Cleared May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · LJN
DiaSorin, Inc.
Microbiology · 18d
Cleared May 14, 1999
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT...
K991550 · LPL
Wesley Jessen Corp.
Ophthalmic · 10d
Cleared May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · KXK
Uromed Corp.
Radiology · 323d
Cleared May 13, 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · DXN
Datascope Corp.
Cardiovascular · 212d
Cleared May 13, 1999
LORENZ IMF SCREW
K983728 · DZL
Walter Lorenz Surgical, Inc.
Dental · 203d
Cleared May 13, 1999
ITI DENTAL IMPLANT SYSTEM
K984104 · DZE
Straumann USA
Dental · 177d
Cleared May 13, 1999
PULSEMASTER DENTAL LASER SYSTEM
K984486 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 147d
Cleared May 13, 1999
DMD DIGITAL X-RAY SYSTEM
K990087 · MUH
Dental/Medical Diagnostic Systems, Inc.
Radiology · 122d
Cleared May 13, 1999
HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR
K990479 · EIA
Hygenitek, Inc.
Dental · 86d
Cleared May 13, 1999
3M CLINPRO PROPHY PASTE, MODEL 12611
K990482 · EJR
Minnesota Mining and Mfg. Co.
Dental · 86d
Cleared May 13, 1999
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
K990515 · KNW
International Medical Systems
Gastroenterology & Urology · 84d
Cleared May 13, 1999
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE
K990696 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 71d
Cleared May 13, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
K990698 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 71d
Cleared May 13, 1999
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
K990729 · MQX
Acc Intl.
General Hospital · 69d
Cleared May 13, 1999
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094 · JZO
Diagnostic Products Corp.
Immunology · 42d
Cleared May 13, 1999
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K991096 · JZO
Diagnostic Products Corp.
Immunology · 42d
Cleared May 13, 1999
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
K991129 · KPS
Hitachi Medical Corp. of America
Radiology · 41d
Cleared May 13, 1999
NOVUS VERDI DELIVERY SYSTEMS
K991258 · GEX
Lumenis, Inc.
General & Plastic Surgery · 30d
Cleared May 13, 1999
PHILIPS TOMOSCAN AV-NT
K991278 · JAK
Philips Medical Systems North...
Radiology · 29d
Cleared May 13, 1999
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS,...
K991363 · FRN
Sorenson Medical, Inc.
General Hospital · 23d
Cleared May 13, 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · BTT
Allegiance Healthcare Corp.
Anesthesiology · 15d
Cleared May 13, 1999
ACCLAIM INFUSION PUMP
K991501 · FRN
Abbott Laboratories
General Hospital · 14d