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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54049–54072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2009
SPINAL INJECTION SYSTEM
K083909 · BSP
Laurimed, LLC
Anesthesiology · 78d
Cleared Mar 18, 2009
STAK-CHEX PLUS RETICS
K090137 · GLQ
Streck
Hematology · 56d
Cleared Mar 18, 2009
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K090272 · GZT
Cardinal Health, Inc.
Neurology · 42d
Cleared Mar 18, 2009
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · NEU
C.R. Bard, Inc.
General & Plastic Surgery · 16d
Cleared Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · KCT
Smith & Nephew, Inc.
General Hospital · 16d
Cleared Mar 17, 2009
SMOOTHLIPO
K083478 · GEX
Eleme Medical, Inc.
General & Plastic Surgery · 113d
Cleared Mar 17, 2009
BOND BONE
K083858 · LYC
Augma Biomaterials, Ltd.
Dental · 83d
Cleared Mar 17, 2009
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K090076 · HSN
Tornier
Orthopedic · 64d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 55d
Cleared Mar 17, 2009
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
K090235 · GEX
Cynosure, Inc.
General & Plastic Surgery · 43d
Cleared Mar 17, 2009
EASY MOVING PLUS, SM-XXHF-YY
K090322 · IZL
Sedecal., Sa.
Radiology · 36d
Cleared Mar 16, 2009
OLYMPUS AFP - ALPHA-FETOPROTEIN
K081709 · LOJ
Olympus Life Science Research Europa...
Immunology · 272d
Cleared Mar 16, 2009
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID...
K081830 · DHB
Phadia AB
Immunology · 259d
Cleared Mar 16, 2009
IVENT101
K081845 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 259d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · LON
bioMerieux, Inc.
Microbiology · 213d
Cleared Mar 16, 2009
SERIM DISINTEK GTA 2.1%, MODEL: 5164
K083295 · JOJ
Serim Research Corp.
General Hospital · 126d
Cleared Mar 16, 2009
EUROIMMUN ANTI BP 180-4X ELISA (IGG)
K083615 · OEG
Euroimmun Us, Inc.
Immunology · 98d
Cleared Mar 16, 2009
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
K083763 · LJS
R4 Vascular, Inc.
General Hospital · 88d
Cleared Mar 16, 2009
ZEST NASAL MASK
K083832 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 83d
Cleared Mar 16, 2009
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
K090267 · MOS
Midwest Rf, LLC
Radiology · 41d
Cleared Mar 16, 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2)...
K090514 · FRC
STERIS Corporation
General Hospital · 18d
Cleared Mar 16, 2009
UROCARE
K090552 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Mar 16, 2009
VERADIUS, MODEL 718-130
K090590 · OWB
Philips Medical Systems North America...
Radiology · 12d
Cleared Mar 16, 2009
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
K090597 · LBH
Pascal Co., Inc.
Dental · 11d