FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124537–124560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1990
OPTIMED GLAUCOMA PRESSURE REGULATOR
K903462 · KYF
Optimed, Inc.
Ophthalmic · 76d
Cleared Oct 16, 1990
EBV/EA-CHECK TM TEST KIT
K903612 · LSE
Diagnostic Technology, Inc.
Microbiology · 68d
Cleared Oct 16, 1990
TURBIQUANT MYOGLOBIN
K903687 · DDR
Behring Diagnostics, Inc.
Immunology · 62d
Cleared Oct 16, 1990
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
K903810 · HWC
Ace Medical Co.
Orthopedic · 57d
Cleared Oct 16, 1990
ACE CANNULATED CORTICAL BONE SCREW
K903811 · HWC
Ace Medical Co.
Orthopedic · 57d
Cleared Oct 16, 1990
GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY
K903840 · DYB
Intec Medical, Inc.
Cardiovascular · 56d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
K903927 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
K903928 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · LIN
Baxter Healthcare Corp
Microbiology · 41d
Cleared Oct 16, 1990
DACRON R SURGICAL SUTURES
K904263 · GAS
Sharppoint, Inc.
General & Plastic Surgery · 29d
Cleared Oct 16, 1990
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · LYF
Meridian Diagnostics, Inc.
Microbiology · 25d
Cleared Oct 15, 1990
DEMISTIFIER ISOLATION CHAMBER
K902161 · CBN
Peace Medical, Inc.
Anesthesiology · 153d
Cleared Oct 15, 1990
GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR
K902906 · FLI
Gas-Vak
General Hospital · 104d
Cleared Oct 15, 1990
QUICK CHECK 3 FILM
K903191 · CGA
Quantai Biotronics, Inc.
Chemistry · 88d
Cleared Oct 15, 1990
MODEL C286 ISOLETTE INFANT INCUBATOR
K903378 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 77d
Cleared Oct 15, 1990
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
K903626 · JJG
Beckman Instruments, Inc.
Chemistry · 66d
Cleared Oct 15, 1990
WILSON-COOK ASPIRATION HANDLE
K903668 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 15, 1990
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
K903738 · DGC
Quidel Corp.
Immunology · 60d
Cleared Oct 15, 1990
ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE
K903742 · DHB
Diagnostic Products Corp.
Immunology · 61d
Cleared Oct 15, 1990
MAXI TEST
K904016 · JHI
Bhc Biotech , Ltd.
Chemistry · 41d
Cleared Oct 15, 1990
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)
K904100 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 39d
Cleared Oct 15, 1990
V-TREND TARGET RF TEST
K904105 · DHR
Texas Immunology, Inc.
Immunology · 39d
Cleared Oct 15, 1990
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168 · CGA
Boehringer Mannheim Corp.
Chemistry · 34d