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
114889–114912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1993
PEG PREP TRAY
K920493 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 336d
Cleared Jan 04, 1993
PANDA NEEDLE CATHETER JEJUNOSTOMY KIT
K921127 · KNT
Knight Medical, Inc.
Gastroenterology & Urology · 300d
Cleared Jan 04, 1993
SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT
K923283 · KKX
Savoy Medical Supply Co., Inc.
General Hospital · 182d
Cleared Jan 04, 1993
ROCHE REAGENT FOR AST
K924244 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 133d
Cleared Jan 04, 1993
OLYMPUS CREATINE KINASE REAGENT
K924832 · CGS
Olympus Corp.
Chemistry · 101d
Cleared Jan 04, 1993
EP 3000
K924879 · JAA
Oec-Diasonics, Inc.
Radiology · 98d
Cleared Jan 04, 1993
UREA NITROGEN TEST
K925002 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Jan 04, 1993
ABBOTT TDX/TDXFLX TT4
K925109 · CDX
Abbott Laboratories
Chemistry · 87d
Cleared Jan 04, 1993
DPD-510 THERAPEUTIC RADIATION DOSIMETER
K925133 · IWB
Scanditronix, Inc.
Radiology · 83d
Cleared Dec 31, 1992
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392 · KWP
Acromed Corp.
Orthopedic · 336d
Cleared Dec 31, 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090 · KWP
Acromed Corp.
Orthopedic · 300d
Cleared Dec 30, 1992
NEUROLOGICAL SPONGE
K914600 · HBA
I M, Inc.
Neurology · 446d
Cleared Dec 30, 1992
BRAINSCAN BRACHYTHERAPY MODULE
K920880 · KXK
Brainlab
Radiology · 308d
Cleared Dec 30, 1992
PRESSSION, SEQUENTIAL
K921608 · JOW
Chattanooga Group, Inc.
Cardiovascular · 271d
Cleared Dec 30, 1992
BRAIDED POLYESTER SUTURE MATERIAL
K923161 · GAS
Mitek Surgical Products, Inc.
General & Plastic Surgery · 184d
Cleared Dec 30, 1992
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
K923402 · BZQ
Pro-Tech, Inc.
Anesthesiology · 173d
Cleared Dec 30, 1992
ERCP CANNULA
K924107 · FGE
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 139d
Cleared Dec 30, 1992
CINENET CARDIAC IMAGE NETWORK
K924708 · IZI
Sony Medical Systems
Radiology · 103d
Cleared Dec 30, 1992
ANCOR
K924719 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 100d
Cleared Dec 30, 1992
MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL
K924756 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 98d
Cleared Dec 30, 1992
4 SURE TM ANESTHESIA EXTENSION SET
K924995 · BSO
Boston Pacific Medical, Inc.
Anesthesiology · 90d
Cleared Dec 30, 1992
BARBITURATE EIA TEST
K925491 · DIS
Diagnostic Reagents, Inc.
Toxicology · 58d
Cleared Dec 30, 1992
LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION
K925903 · GEI
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 48d
Cleared Dec 30, 1992
CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT
K926082 · IZI
Biodan Medical Systems, Ltd.
Radiology · 29d