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
168001–168024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 1980
CIRCAMED I
K800214 · DSH
Circadian, Inc.
Cardiovascular · 28d
Cleared Feb 29, 1980
MODEL 412 ELECTROFLUIDIC MANOMETER
K800222 · DXW
Med-Tek Corp.
Cardiovascular · 25d
Cleared Feb 29, 1980
OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
K800360 · DSK
Output, Inc.
Cardiovascular · 9d
Cleared Feb 28, 1980
LEUKOFIX POROS
K792726 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 59d
Cleared Feb 28, 1980
USCI SAUVAGE EXS VASCULAR PROSTHESIS
K800149 · DSY
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Feb 28, 1980
DAHLBERG # AF BEHING THE EAR HEARING/AID
K800181 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 30d
Cleared Feb 28, 1980
FOLEY CATHETER
K800306 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
IRRIGATION (3-WAY) FOLEY CATHETER
K800307 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
PEDIATRIC FOLEY CATHETER
K800308 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
CONCEPT SUCTION COAGULATOR
K800321 · KNS
Concept, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
TRI PAC MOUTH PROP
K800369 · JXL
Oxequip Health Ind.
Neurology · 8d
Cleared Feb 28, 1980
WILL CERAM LITE-CAST B
K800371 · EJH
Williams Gold Refining Co., Inc.
Dental · 8d
Cleared Feb 28, 1980
ARGYLE TRU-VOL
K800386 · BWF
Sherwood Medical Co.
Anesthesiology · 6d
Cleared Feb 26, 1980
PHARMAFLEX CRYOGENIC BAG
K792395 · KSR
Pharmachem Corp.
Hematology · 92d
Cleared Feb 26, 1980
PLS MINI
K792501 · BWJ
Staodynamics, Inc.
General Hospital · 84d
Cleared Feb 26, 1980
POINT LOCATOR STIMULATOR
K792529 · BWJ
Staodynamics, Inc.
General Hospital · 81d
Cleared Feb 26, 1980
SURGITEK URINARY DIVERSION STENT
K800109 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 41d
Cleared Feb 26, 1980
LOGO-NU-WAY
K800186 · KNX
Gary Giancarlo
Gastroenterology & Urology · 28d
Cleared Feb 26, 1980
ANAGO DISP., ALL PURPOSE PATIENT REST.
K800197 · FQM
Anago, Inc.
General Hospital · 27d
Cleared Feb 26, 1980
ESOPHAGEAL PILL-ELECTRODE
K800201 · DRX
Arzbaecher & Co.
Cardiovascular · 27d
Cleared Feb 26, 1980
PHARMACY ADDITIVE SYRINGE SET
K800213 · KYW
Cutter Laboratories, Inc.
General Hospital · 25d
Cleared Feb 26, 1980
SODIUM/POTASSIUM CONDITIONING REAGENT
K800216 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CHLORIDE REAGENT, CUP & CLEANER
K800217 · JFS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218 · JFL
Fisher Scientific Co., LLC
Chemistry · 22d