FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85801–85824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 12, 1999
ROCS ULTRASEED
K984241 · IYE
Radiation Oncology Computer Systems
Radiology · 166d
Cleared May 12, 1999
CALCIUM SCORING
K990426 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 12, 1999
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
K990441 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared May 12, 1999
1000 PRESSURE INFUSION SIGMACON 1000
K990447 · FRN
Valley West, Inc.
General Hospital · 89d
Cleared May 12, 1999
PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
K990455 · LLZ
Philips Medical Systems, Inc.
Radiology · 89d
Cleared May 11, 1999
TRACER O-T-W MAPPING DEVICE
K972803 · DRF
Cardima, Inc.
Cardiovascular · 652d
Cleared May 11, 1999
DBEST OCCULT BLOOD TEST KIT
K984269 · KHE
Ameritek, Inc.
Hematology · 201d
Cleared May 11, 1999
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K990011 · LPL
Continental Soft Lens, Inc.
Ophthalmic · 127d
Cleared May 11, 1999
CALCITONIN
K990073 · JKR
Kmi Diagnostics, Inc.
Chemistry · 120d