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
138841–138864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450
K873238 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463
K873239 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUSION AGAR W/ C&C SLANT TUBE #T3285
K873240 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM
K873241 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM
K873242 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286
K873243 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP
K873244 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 39d
Cleared Sep 22, 1987
ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
K873249 · LKJ
Cytotech, Inc.
Immunology · 36d
Cleared Sep 22, 1987
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282 · KLT
Windsor Laboratories, Inc.
Toxicology · 36d
Cleared Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · LAN
Em Diagnostic Systems, Inc.
Toxicology · 33d
Cleared Sep 22, 1987
WAKO(TM) PRETEST 8A
K873553 · JJB
Wako Chemicals USA, Inc.
Chemistry · 25d
Cleared Sep 22, 1987
AUTO-EIA
K873583 · JJQ
Labsystems, Inc.
Chemistry · 19d
Cleared Sep 22, 1987
FINNIGAN MAT INCOS 50
K873603 · JJO
Finnigan Corp.
Chemistry · 18d
Cleared Sep 21, 1987
AN3200 DOUBILET DRAIN
K872458 · FGE
H.W. Andersen Products, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 21, 1987
REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION
K872476 · MHX
Energy Concepts, Inc.
Cardiovascular · 90d
Cleared Sep 21, 1987
ELASTO-GEL CAST & SPLINT PADS
K872488 · IPM
Southwest Technologies, Inc.
Physical Medicine · 90d
Cleared Sep 21, 1987
OPHTHALMIC PHACO-BLADE
K873385 · HNN
Myocure, Inc.
Ophthalmic · 28d
Cleared Sep 21, 1987
RULE, PUPILLARY
K873440 · HMM
Allegheny Plastics, Inc.
Ophthalmic · 25d
Cleared Sep 21, 1987
TRI-LEVEL LIGAND CONTROL
K873450 · JJX
Ciba Corning Diagnostics Corp.
Immunology · 25d
Cleared Sep 18, 1987
DURAPHASE PENILE PROSTHESIS
K871653 · FAE
Dacomed Corp.
Gastroenterology & Urology · 143d
Cleared Sep 18, 1987
CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
K872034 · DRN
Cardiomedics, Inc.
Cardiovascular · 114d
Cleared Sep 18, 1987
CALCIUM CALIBRATOR
K872051 · JIS
Wako Chemicals USA, Inc.
Chemistry · 113d
Cleared Sep 18, 1987
MODIFIED VERSA STIM ELECTRODE LINE
K872368 · DRO
Conmedcorp
Cardiovascular · 92d
Cleared Sep 18, 1987
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400
K872586 · BXB
Invacare Corp.
Physical Medicine · 79d