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
87169–87192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1999
IMAGEFUSION 2.0
K990071 · MUJ
Radionics, Inc.
Radiology · 28d
Cleared Feb 08, 1999
MILLENNIUM MLC -120
K990085 · IYE
Varian Assoc., Inc.
Radiology · 28d
Cleared Feb 05, 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO...
K982938 · DJR
Phamatech
Toxicology · 168d
Cleared Feb 05, 1999
VIRILIS PENILE PROSTHESIS
K983015 · FTQ
Specialty Surgical Products, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 05, 1999
ACCU-CHEK HQ SYSTEM
K983047 · LFR
Boehringer Mannheim Corp.
Chemistry · 157d
Cleared Feb 05, 1999
OMNIFLATOR 7640 MODEL 7-640-00
K983326 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 136d
Cleared Feb 05, 1999
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
K983372 · DRS
Sunscope Intl., Inc.
Cardiovascular · 134d
Cleared Feb 05, 1999
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING...
K983596 · MQH
Cook Ob/Gyn
Obstetrics & Gynecology · 115d
Cleared Feb 05, 1999
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
K983626 · DXH
Alaris Medical Systems, Inc.
Cardiovascular · 113d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
K983694 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
K983695 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
K983696 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
K984091 · IZH
Trex Medical Corp.
Radiology · 81d
Cleared Feb 05, 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092 · IZH
Trex Medical Corp.
Radiology · 81d
Cleared Feb 05, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS...
K984166 · CGN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 77d
Cleared Feb 05, 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · HSD
Howmedica, Inc.
Orthopedic · 73d
Cleared Feb 05, 1999
ABBOTT ARCHITECT FOLATE
K984301 · CGN
Abbott Laboratories
Chemistry · 65d
Cleared Feb 05, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
K984520 · CGR
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Feb 04, 1999
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · KCT
Medicel, S.A. DE C.V.
General Hospital · 563d
Cleared Feb 04, 1999
NUTRISAFE ENTERAL FEEDING TUBE
K981629 · FPD
Schiff & Co.
Gastroenterology & Urology · 273d
Cleared Feb 04, 1999
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
K981733 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 262d
Cleared Feb 04, 1999
DIODE LASER
K982119 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 233d
Cleared Feb 04, 1999
GENICON TROCAR
K982472 · GEA
Genicon, LC
General & Plastic Surgery · 204d