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
146425–146448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266 · GTZ
Abbott Laboratories
Microbiology · 191d
Cleared Dec 05, 1985
LBK 1244 DELFIA HCG KIT
K852760 · JHI
Lkb Instruments, Inc.
Chemistry · 160d
Cleared Dec 05, 1985
ADDITIVE EXTENSION SYRINGE
K853120 · FMF
Abbott Laboratories
General Hospital · 133d
Cleared Dec 05, 1985
REPLACEMENT PUMP TUBING
K853621 · JJE
Shaban Mfg. Co.
Chemistry · 98d
Cleared Dec 05, 1985
RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
K853848 · BXW
Medical Graphics Corp.
Anesthesiology · 80d
Cleared Dec 05, 1985
COMPUTERIZED RADIATION TREATMENT PLANNING SYS
K853964 · LHN
Computerized Medical Systems, Inc.
Radiology · 80d
Cleared Dec 05, 1985
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057 · JHO
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Dec 05, 1985
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
K854104 · JHI
Immunchem Corp.
Chemistry · 58d
Cleared Dec 05, 1985
I.V. WATCH
K854172 · FPB
Alltek, Inc.
General Hospital · 51d
Cleared Dec 05, 1985
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · JJQ
Terumo Medical Corp.
Chemistry · 50d
Cleared Dec 05, 1985
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
K854324 · CDX
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 38d
Cleared Dec 05, 1985
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU
K854392 · LFW
Windsor Laboratories, Inc.
Toxicology · 35d
Cleared Dec 05, 1985
CHURCHILL-H NON-VENTED IV SET
K854435 · FPA
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
CHURCHILL-H SCALP VEIN SET
K854436 · FPA
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
CHURCHILL-H VENTED IV SET
K854437 · FPA
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Dec 05, 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · CHL
Nova Biomedical Corp.
Chemistry · 17d
Cleared Dec 04, 1985
CARDIAC COMMUNICATOR 2000
K852654 · DSI
Creative Medical, Inc.
Cardiovascular · 163d
Cleared Dec 04, 1985
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A
K852710 · DTB
Telectronics, Inc.
Cardiovascular · 161d
Cleared Dec 04, 1985
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
K852976
American Micro Scan
Microbiology · 142d
Cleared Dec 04, 1985
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA
K853294 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 110d
Cleared Dec 04, 1985
MEDTRONIC MODEL 5062
K853398 · DTB
Medtronic Vascular
Cardiovascular · 114d
Cleared Dec 04, 1985
ELECTROLYTE ANALYZER SERA-252
K853405 · CHL
Horiba Instruments, Inc.
Chemistry · 114d
Cleared Dec 04, 1985
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08
K853517 · DTB
Intermedics, Inc.
Cardiovascular · 104d