Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
138289–138312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1987
IMMUSTRIP(TM) SM ELISA TEST SYSTEM
K873741 · LKP
Immunomedics, Inc.
Immunology · 49d
Cleared Nov 04, 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · DHB
Incstar Corp.
Immunology · 36d
Cleared Nov 04, 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998 · DHB
3M Company
Immunology · 34d
Cleared Nov 04, 1987
SHOE COVERS
K874064 · FXP
Interpro Intl., Inc.
General Hospital · 30d
Cleared Nov 04, 1987
LAPAROTOMY SPONGES
K874065 · EFQ
Interpro Intl., Inc.
General & Plastic Surgery · 30d
Cleared Nov 04, 1987
SURGICAL CAPS
K874066 · FYF
Interpro Intl., Inc.
General & Plastic Surgery · 30d
Cleared Nov 04, 1987
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · JJJ
Lkb Instruments, Inc.
Chemistry · 35d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · LKJ
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Nov 04, 1987
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · JJT
Helena Laboratories
Chemistry · 22d
Cleared Nov 04, 1987
FALSE RAGWEED ALLERGEN DISC
K874149 · DHB
Incstar Corp.
Hematology · 22d
Cleared Nov 04, 1987
JOHNSON GRASS ALLERGEN DISC
K874150 · DHB
Incstar Corp.
Immunology · 22d
Cleared Nov 04, 1987
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Nov 04, 1987
DART (R) ELECTROLYTE REAGENT SYSTEM
K874185 · JGS
Coulter Electronics, Inc.
Chemistry · 21d
Cleared Nov 04, 1987
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
K874248 · LCX
Syntron Bioresearch, Inc.
Chemistry · 19d
Cleared Nov 03, 1987
INTELECT 775
K872655 · IPF
Chattanooga Group, Inc.
Physical Medicine · 119d
Cleared Nov 03, 1987
IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
K872764 · FRN
Y
General Hospital · 113d
Cleared Nov 03, 1987
CANNABINOID ENZYME IMMUNOASSAY KIT
K872882 · LDJ
General Diagnostics
Toxicology · 104d
Cleared Nov 03, 1987
BLOOD NEEDLE HOLDER
K873569 · FMI
Sage Products, Inc.
General Hospital · 62d
Cleared Nov 03, 1987
3 RING ATTACHMENT FOR SYRINGES
K873709 · FMF
Condor Medical
General Hospital · 49d
Cleared Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · LDF
Deknatel, Inc.
Cardiovascular · 48d
Cleared Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · LJT
Medtronic Vascular
General Hospital · 49d
Cleared Nov 03, 1987
THERMOCOUPLE ADAPTER
K873833 · FLL
Mallinckrodt Critical Care
General Hospital · 43d
Cleared Nov 03, 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858 · CDP
Amersham Corp.
Chemistry · 42d
Cleared Nov 03, 1987
PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET
K873885 · FPA
Pharmacia Deltec, Inc.
General Hospital · 41d