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
163585–163608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1981
NICHOLE'S 99
K812075 · CAH
Healthcare Ind.
General Hospital · 21d
Cleared Aug 12, 1981
ANTI-GM & ANTI-KM TYPING SERUMS
K812076 · DGH
Biotest-Serum-Institut
Immunology · 21d
Cleared Aug 12, 1981
WAKO NEFA C TEST
K812081 · JLG
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared Aug 12, 1981
FAST CHOLES-CINET
K812091 · CHH
Sclavo, Inc.
Chemistry · 20d
Cleared Aug 12, 1981
SERALYZER
K812100 · CHH
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Aug 10, 1981
ATL'S MARK 100/300 ULTRASOUND SYSTEMS
K811572 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 67d
Cleared Aug 10, 1981
ARROW PERITONEAL LAVAGE CATHERIZATION K
K811627 · GBW
Arrow Intl., Inc.
General & Plastic Surgery · 62d
Cleared Aug 10, 1981
UROSKOP C
K811807 · KPR
Siemens Corp.
Radiology · 46d
Cleared Aug 07, 1981
TYPE FH ENDOCARDIAL LEAD
K810494 · DTB
Biotronik Sales, Inc.
Cardiovascular · 164d
Cleared Aug 07, 1981
MS-50 ULTRASONIC IMAGER
K811252 · IYO
Kontron Instruments, Inc.
Radiology · 94d
Cleared Aug 07, 1981
PLAYTEX DIGITAL TAMPON
K811385 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
PLAYTEX COMBINATION FIBER MODIFIED TAMP
K811387 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
PLAYTEX COTTON DIGITAL TAMPON
K811388 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
PLAYTEX COTTON TAMPONS
K811389 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
CROUCH CORNEAL PROTECTOR
K811577 · HOY
Denver Biomedicals, Inc.
Ophthalmic · 63d
Cleared Aug 07, 1981
LAPAROTOMY PADS
K811769 · GDY
South Mountain Medical
General & Plastic Surgery · 46d
Cleared Aug 07, 1981
BACTASHIELD
K811859 · FIB
Tri-Med, Inc.
Gastroenterology & Urology · 37d
Cleared Aug 07, 1981
ADAPTAID LEAD ADAPTER #365-25
K811938 · DTD
Intermedics, Inc.
Cardiovascular · 32d
Cleared Aug 07, 1981
VISITEC NEDDLE TANGE (SURGERY)
K811960
Visitec Co.
General & Plastic Surgery · 28d
Cleared Aug 07, 1981
NEUROGAR III
K812036 · GZJ
Inter Med Industries, Inc.
Neurology · 18d
Cleared Aug 07, 1981
TIDAL VOLUME MONITOR 150
K812046 · BZK
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 17d
Cleared Aug 07, 1981
IDS BETA-LACTAMASE DISC
K812047 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 18d
Cleared Aug 04, 1981
BOUNDARY STERILIZATION WRAP
K811819 · FRG
The Buckeye Cellulose Corp.
General Hospital · 36d
Cleared Aug 04, 1981
CALIBRATED BREATHING SYSTEM COLLECTION
K811955 · KDQ
Anchor Brush Co., Inc.
General Hospital · 34d