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
138097–138120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1987
INFUSION MANIFOLD
K873852 · FPK
Advanced Surgical Products, Inc.
General Hospital · 62d
Cleared Nov 23, 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · CFR
Baxter Healthcare Corp
Chemistry · 59d
Cleared Nov 23, 1987
A-GENT LIQUID AMYLASE
K873944 · JFJ
Abbott Laboratories
Chemistry · 56d
Cleared Nov 23, 1987
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945 · CDP
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Nov 23, 1987
DISPOSABLE BIPOLAR FORCEPS
K873978 · GEN
E.M. Adams
General & Plastic Surgery · 54d
Cleared Nov 23, 1987
ACU-MICRO-NEEDLE
K874024 · FMI
Acuderm, Inc.
General Hospital · 52d
Cleared Nov 23, 1987
MAMEX DC S SL10/MG14
K874040 · IZH
Orion Corp.
Radiology · 49d
Cleared Nov 23, 1987
INFLATABLE FOOT & ANKLE SPLINT
K874050 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
INFLATABLE FULL LEG SPLINT
K874051 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
INFLATABLE HALF LEG SPLINT
K874052 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
INFLATABLE FULL ARM SPLINT
K874053 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
360D DC DEFIBRILLATOR
K874091 · LDD
Medac, Inc.
Cardiovascular · 47d
Cleared Nov 23, 1987
TITAN GEL REP LDH-12 HV
K874143 · CFE
Helena Laboratories
Chemistry · 41d
Cleared Nov 23, 1987
TITAN GEL REP CPK-6 HV
K874144 · JHX
Helena Laboratories
Chemistry · 41d
Cleared Nov 23, 1987
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER
K874155 · KRC
Circadian, Inc.
Cardiovascular · 41d
Cleared Nov 23, 1987
PATIENT TEMPERATURE MONITOR, MODEL 1000
K874159 · FLL
Sonodyne America, Ltd.
General Hospital · 41d
Cleared Nov 23, 1987
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163 · CIX
Catachem, Inc.
Chemistry · 41d
Cleared Nov 23, 1987
S3 MEDICATED GAUZE
K874219 · FRO
Surgical Specialties, Inc.
General & Plastic Surgery · 38d
Cleared Nov 23, 1987
PRECINORM L
K874230 · JJY
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Nov 23, 1987
IRON HORSE ONE
K874246 · IOR
Iron Horse Productions, Inc.
Physical Medicine · 38d
Cleared Nov 23, 1987
VENTRESCREEN, HCG URINE
K874258 · JHI
Ventrex Laboratories, Inc.
Chemistry · 34d
Cleared Nov 23, 1987
WAKO(TM) FE C
K874263 · JIY
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Nov 23, 1987
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
K874299 · CEW
Incstar Corp.
Chemistry · 34d
Cleared Nov 23, 1987
SKIN PREP ANALYZER
K874327 · KRC
Marquette Electronics, Inc.
Cardiovascular · 33d