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
148921–148944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1985
ORTHOPEDIC IMPLANT PLATES
K850025 · HRS
Kirkstil Corp., Inc.
Orthopedic · 137d
Cleared May 20, 1985
ORTHOPEDIC IMPLANT NAILS & PINS
K850026 · HTY
Kirkstil Corp., Inc.
Orthopedic · 137d
Cleared May 20, 1985
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS
K850354 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 110d
Cleared May 20, 1985
ELECTROSURGICAL UNIT 774
K850668 · GEI
Birtcher Corp.
General & Plastic Surgery · 89d
Cleared May 20, 1985
CONCEPT VIDEO IMAGING SYSTEM
K850749 · KQM
Concept, Inc.
General & Plastic Surgery · 84d
Cleared May 20, 1985
TOXOSCAN CARD TEST KIT
K850768 · LLA
Bd Becton Dickinson Vacutainer...
Microbiology · 84d
Cleared May 20, 1985
MODEL 775 BIPOLAR COAGULATOR
K850943 · GEI
Birtcher Corp.
General & Plastic Surgery · 74d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR I
K851150 · JIX
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR II
K851151 · JIX
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
MICROSTATIC URINE TRANSPORT TUBE FOR C & S
K851387 · LIO
Analytical Luminescence Laboratory, Inc.
Microbiology · 41d
Cleared May 20, 1985
ULTRA-VIOLET BUN REAGENT KIT
K851513 · CDQ
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared May 20, 1985
ULTRA-VIOLET GLUCOSE REAGENT
K851514 · CFA
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared May 20, 1985
TRIGLYCERIDE(TRINDER) PROCEDURE
K851538 · CDT
Data Medical Associates, Inc.
Chemistry · 34d
Cleared May 20, 1985
NOVASPEC VISIBLE SPECTROPHOTOMETER
K851572 · JJQ
Lkb Instruments, Inc.
Toxicology · 33d
Cleared May 20, 1985
TDX TOTAL T3
K851676 · CDP
Abbott Laboratories
Chemistry · 27d
Cleared May 20, 1985
CREATINE LIQUID STABLE REAGENT SET
K851849 · CGX
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared May 20, 1985
MCDB 302 MEDIUM, M2021
K851862 · KIT
Sigma Cell Culture Reagents
Pathology · 24d
Cleared May 20, 1985
NCTC-135 MEDIUM N3262
K851863 · KIT
Sigma Cell Culture Reagents
Pathology · 24d
Cleared May 20, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851865 · CIT
Amresco, Inc.
Chemistry · 21d
Cleared May 20, 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877 · CEK
Medical Analysis Systems, Inc.
Chemistry · 21d
Cleared May 20, 1985
MULTI FUNCTION BLOOD GAS CONTROL
K851911 · JJS
Bionostics, Inc.
Chemistry · 19d
Cleared May 20, 1985
VERO GENCELLS
K851927 · KIR
Genus Diagnostics
Pathology · 18d
Cleared May 20, 1985
HEK GENCELLS
K851928 · KIR
Genus Diagnostics
Pathology · 18d
Cleared May 20, 1985
ORIGINAL ULTRAVIOLET SUNTANNING LAMP
K852053 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 11d