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
157921–157944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1983
ONE TIME DISPOSABLE SKIN STAPLER
K830704 · FZQ
Acme United Corp.
General & Plastic Surgery · 36d
Cleared Apr 12, 1983
WIRE TWISTERS
K830721 · HTC
The Anspach Effort, Inc.
General & Plastic Surgery · 35d
Cleared Apr 12, 1983
REDI-DRAPE
K830723 · KKX
The Oec Group
General Hospital · 35d
Cleared Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
K830734 · DQO
American Edwards Laboratories
Cardiovascular · 35d
Cleared Apr 12, 1983
ADT DISPOSABLE SCALPEL W/STAINLESS STEEL
K830745 · GDX
Lab Industries, Inc.
General & Plastic Surgery · 35d
Cleared Apr 12, 1983
OLYMPUS HIGH SPEED ANALYZER
K830762 · JJE
Olympus Corp.
Chemistry · 33d
Cleared Apr 12, 1983
DISPOSABLE SKIN STAPLER
K830768 · FZQ
Surgeons Choice, Inc.
General & Plastic Surgery · 32d
Cleared Apr 12, 1983
CADWELL 8400
K830771 · GWF
Cadwell Laboratories, Inc.
Neurology · 32d
Cleared Apr 12, 1983
AMES TDA VALPROIC ACID TEST
K830789 · LEG
Miles Laboratories, Inc.
Chemistry · 29d
Cleared Apr 12, 1983
INDUCTIVELY-COUPLED PLASMA SPECTROMETER
K830799 · JXR
The Perkin-Elmer Corp.
Toxicology · 29d
Cleared Apr 12, 1983
DSL 1900
K830816 · CGI
Diagnostic Systems
Chemistry · 28d
Cleared Apr 12, 1983
ASAHI BLOOD/PLASMA PUMP #ABP-01A &
K830818 · FIR
Parker Hannifin Corp.
Gastroenterology & Urology · 28d
Cleared Apr 12, 1983
NEGATIVE URINE CONTROL
K830834 · JJW
Helena Laboratories
Chemistry · 27d
Cleared Apr 12, 1983
REFLEX ONE STAPLE EXTRACTOR
K830867
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 25d
Cleared Apr 12, 1983
TITAN GEL LDH ISO-ENZYME CONTROL
K830872 · CFE
Helena Laboratories
Chemistry · 25d
Cleared Apr 12, 1983
THREE CHANNEL MONITOR SERIES 6700
K830899 · DXJ
Marquette Electronics, Inc.
Cardiovascular · 22d
Cleared Apr 12, 1983
TDX T-UPTAKE
K830912 · KHQ
Abbott Laboratories
Chemistry · 22d
Cleared Apr 12, 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
K830917 · FAE
Medical Engineering Corp.
Gastroenterology & Urology · 21d
Cleared Apr 12, 1983
TREONIC IP5
K830936 · FRN
Vickers America Medical Corp.
General Hospital · 19d
Cleared Apr 12, 1983
SUR-FIT FLEXIBLE
K830945 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 19d
Cleared Apr 12, 1983
SYRINGE/NEEDLE DISPOS-BOX-CUTTER/CRIMPER
K830947
Post Medical, Inc.
General & Plastic Surgery · 19d
Cleared Apr 12, 1983
POLYETHYLENE MEDULLARY PLUG - STIIHMER/
K830949 · LZN
Allo Pro Corp.
Orthopedic · 19d
Cleared Apr 12, 1983
EASY BREATHER HEADER BAGS
K830961 · KCT
Medical Industries Packaging, Inc.
General Hospital · 18d
Cleared Apr 12, 1983
DOUBLE LUMEN TRANSFER DEVICE
K830970 · LHI
Codan Trading Co.
General Hospital · 15d