FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120241–120264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1991
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
K912002 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 98d
Cleared Aug 12, 1991
MODIFIED SERIES 2100 ENDOSCOPES
K912089 · ODF
Medical Laser, Inc.
Gastroenterology & Urology · 91d
Cleared Aug 12, 1991
URESIL GENERAL PURPOSE DRAINAGE CATHETER
K912109 · GBO
Uresil Corp.
General & Plastic Surgery · 91d
Cleared Aug 12, 1991
CHOLINESTERASE TEST KIT
K912148 · DIH
Crestat Diagnostics, Inc.
Toxicology · 89d
Cleared Aug 12, 1991
CELLABS GIARDIA CEL I.F. TEST
K912152 · MHI
Celltech Diagnostics , Ltd.
Microbiology · 89d
Cleared Aug 12, 1991
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
K912295 · LZO
Kinamed, Inc.
Orthopedic · 82d
Cleared Aug 12, 1991
SURG/ASSIST MODEL SA-1
K912422 · FYD
Surg-Assist, Inc.
General Hospital · 73d
Cleared Aug 12, 1991
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
K912455 · JJY
Baxter Healthcare Corp
Chemistry · 70d
Cleared Aug 12, 1991
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · CDX
Diagnostic Products Corp.
Chemistry · 63d
Cleared Aug 12, 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Aug 12, 1991
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 61d
Cleared Aug 12, 1991
ERECAID(R) SYSTEM PLUS
K912736 · LKY
Osbon Medical Systems, Ltd.
Gastroenterology & Urology · 52d
Cleared Aug 12, 1991
AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS
K912738 · FRN
3M Avi, Inc.
General Hospital · 52d
Cleared Aug 12, 1991
STASIS BUTTON PRSSURE DEVICE
K912765 · MHW
Arch Development Group
General & Plastic Surgery · 49d
Cleared Aug 12, 1991
BIOTROL UIBC REAGENT
K912795 · JMO
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Aug 12, 1991
FSH IRMA IMMUNOMAG
K912804 · CGJ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 48d
Cleared Aug 12, 1991
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
K912809 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 12, 1991
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
K912827 · DKC
Cala Diagnostics
Chemistry · 47d
Cleared Aug 12, 1991
SHBG
K912850 · CDZ
Wien Laboratories, Inc.
Chemistry · 45d
Cleared Aug 12, 1991
MONOSCOPY(TM) BRANK, HOOK DISSECTOR
K912862 · GCJ
Dexide, Inc.
General & Plastic Surgery · 46d
Cleared Aug 12, 1991
REFLOTRON CREATININE TEST TABS
K913105 · JFY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Aug 12, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
K913124 · JIF
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
K913125 · DIC
Roche Diagnostic Systems, Inc.
Chemistry · 28d