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
152161–152184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1984
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · JBQ
Instrumentation Laboratory CO
Hematology · 132d
Cleared Sep 06, 1984
C-PEP-RIA-100
K842267 · JKD
Institut National Des Radioelements
Chemistry · 90d
Cleared Sep 06, 1984
HEMATOLOGY ANALYZER
K842310 · JKL
Hml Inc/Biotechnology Transfer
Hematology · 86d
Cleared Sep 06, 1984
DILU-MATIC 140
K842446 · GKH
Abbott Diagnostics
Hematology · 77d
Cleared Sep 06, 1984
CELL-MATICS VIRAL TRANSPORT PACK
K843173 · JTW
Difco Laboratories, Inc.
Microbiology · 24d
Cleared Sep 06, 1984
BHK-21
K843250 · KIR
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 06, 1984
RD CELLS
K843251 · KIR
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 06, 1984
AFRICAN GREEN SV 5/SV 40
K843252 · KIR
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 05, 1984
COMBION SKIN TEST - FOUR PRONG
K833999 · SCL
Nicholas H. Maganias
General Hospital · 289d
Cleared Sep 05, 1984
CK10000 SERIES POUCH & BAGS ETC.
K834558 · KCT
Currie Medical Specialties, Inc.
General Hospital · 252d
Cleared Sep 05, 1984
COLOTRAK OCCULT BLOOD TEST
K840527 · KHE
Breit Laboratories, Inc.
Hematology · 211d
Cleared Sep 05, 1984
AUTOLYZER 800
K841852 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 125d
Cleared Sep 05, 1984
DOSE RELEASE OF STERILIZATION LOTS
K841949 · FMF
Medcare Disp Products, Inc.
General Hospital · 114d
Cleared Sep 05, 1984
COMBO SKIN TEST READY TO USE TAPE
K842107 · SCL
Combion Systems, Inc.
General Hospital · 99d
Cleared Sep 05, 1984
OCCULT BLOOD TEST
K842137 · KHE
Breit Laboratories, Inc.
Hematology · 98d
Cleared Sep 05, 1984
DISPOSABLE STOPCOCKS
K842173 · FMG
Procedure Products, Inc.
General Hospital · 113d
Cleared Sep 05, 1984
AMIZYME-SCHISTOSOMA SPP. TEST KIT
K842527 · GNH
Amico Lab, Inc.
Microbiology · 69d
Cleared Sep 05, 1984
CUSTOM CANAL HEARING AID X-CITE 84
K842546 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 05, 1984
OMED DISPOS. INSTRUMENT GUARDS
K842603
Omega-Med Intl., Inc.
General & Plastic Surgery · 62d
Cleared Sep 05, 1984
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT
K842692 · JHI
Quidel Corp.
Chemistry · 56d
Cleared Sep 05, 1984
EMIT D.A.U. LOW & MED. CALIBRATORS B
K842816 · DKB
Syva Co.
Toxicology · 49d
Cleared Sep 05, 1984
CALCITONIN RADIOIMMUNOASSAY KIT
K842907 · JKR
Nichols Institute Diagnostics
Chemistry · 43d
Cleared Sep 05, 1984
AMERLEX-M FREE T-3 RIA
K842949 · CDP
Amersham Corp.
Chemistry · 61d
Cleared Sep 05, 1984
IN-THE-EAR-CANAL HEARING AID
K842980 · ESD
Ear Care Hearing Systems, Inc.
Ear, Nose, Throat · 37d