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
167425–167448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1980
FIXOMULL STERILE
K800953 · NAD
Beiersdorf, Inc.
General & Plastic Surgery · 27d
Cleared May 20, 1980
CHARNLEY DESIGN HIP PROSTHESIS
K801006 · JDG
Colmed, Ltd.
Orthopedic · 22d
Cleared May 20, 1980
KIRSCHNER WIRE
K801010 · HSB
American Safety Equipment Corp.
Orthopedic · 22d
Cleared May 20, 1980
125I-IGE RADIOIMMUNOASSAY KIT
K801019 · DGC
Bio-Ria
Immunology · 20d
Cleared May 20, 1980
RICA OR SMIC SURGICAL INSTRUMENTS
K801028 · HXD
Robert I. Chien & Assoc., Inc.
General & Plastic Surgery · 19d
Cleared May 20, 1980
STERILE DRAPE 17X18 CODE D-6A
K801032 · KKX
Veratex Corp.
General Hospital · 19d
Cleared May 20, 1980
STERILE DRAPE 17X18 W/3 FENESTRATION
K801033 · KKX
Veratex Corp.
General Hospital · 19d
Cleared May 20, 1980
PLY LESIVE
K801047 · LBH
May-Pell Chemical Development Co.
Dental · 15d
Cleared May 20, 1980
STERILE ABDOMINAL PAD
K801068 · KKX
Medspec Corp.
General Hospital · 14d
Cleared May 20, 1980
STERILE ISOLATION GOWN
K801069 · FYC
Medspec Corp.
General Hospital · 14d
Cleared May 20, 1980
STRAITH CHIN IMPLANTS
K801073 · FWP
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared May 20, 1980
STRAITH CHISEL FORCEPS
K801075 · GEN
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared May 20, 1980
KWIX-BITE X-RAY FILM HOLDER
K801079 · EGZ
Henry Schein, Inc.
Dental · 13d
Cleared May 20, 1980
EDWARDS ROD SLEEVES
K801080 · KWP
Zimmer, Inc.
Orthopedic · 13d
Cleared May 20, 1980
PRISMA-FILL
K801092 · EBF
Dentsply Intl.
Dental · 12d
Cleared May 20, 1980
PRISMA-BOND
K801093 · KLE
Dentsply Intl.
Dental · 12d
Cleared May 20, 1980
SARNS 7000 MONITOR MODULE
K801097 · DTQ
3M Health Care, Sarns
Cardiovascular · 11d
Cleared May 20, 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · DSK
American Optical Corp.
Cardiovascular · 8d
Cleared May 20, 1980
DUNN ANTERIOR DISTRACTION SYSTEM
K801120 · KWP
Zimmer, Inc.
Orthopedic · 8d
Cleared May 20, 1980
BOUNDARY EXTREMITY DRAPE
K801132 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 8d
Cleared May 20, 1980
DISPOSABLE SKIN RETRACTOR
K801151 · GZT
Cimarron Instruments, Inc.
Neurology · 7d
Cleared May 20, 1980
VALLEYLAB RETURN ELECTRODE MONITOR
K801153 · GEI
Valleylab, Inc.
General & Plastic Surgery · 6d
Cleared May 14, 1980
SMEC BALLOON CANNULA
K790755 · DSP
Smec, Inc.
Cardiovascular · 393d
Cleared May 14, 1980
CLEAR-VIEW MIRROR WARMER
K800382 · GET
Surgical Mechanical Research, Inc.
General & Plastic Surgery · 82d