FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128737–128760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1989
OSSEODENT PROSTHETIC KIT
K895333 · DZE
Celtrix Laboratories
Dental · 90d
Cleared Nov 29, 1989
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · DWF
Kendall Healthcare Products Co....
Cardiovascular · 89d
Cleared Nov 29, 1989
ASPIRETTE ENDOCERVICAL ASPIRATOR
K895403 · HFC
Unimar, Inc.
Obstetrics & Gynecology · 83d
Cleared Nov 29, 1989
TOWER SELF SEAL STERILIZATION POUCH
K895422 · JOJ
Baxter Healthcare Corp
General Hospital · 89d
Cleared Nov 29, 1989
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · DQY
Quinton, Inc.
Cardiovascular · 85d
Cleared Nov 29, 1989
SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD
K895519 · HHD
Personal Products Co.
Obstetrics & Gynecology · 78d
Cleared Nov 29, 1989
SICKLE CELL SOLUBILITY TEST KIT
K895745 · JBB
Simmler, Inc.
Hematology · 64d
Cleared Nov 29, 1989
OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER
K895780 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 63d
Cleared Nov 29, 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · LBS
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Nov 29, 1989
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
K895959 · EKJ
Brevet, Inc.
Dental · 49d
Cleared Nov 29, 1989
IMMUNOCARD STREP A TEST
K896109 · GTZ
Disease Detection International, Inc.
Microbiology · 37d
Cleared Nov 29, 1989
MODIFIED RUBAGEN
K896433 · LQN
Biokit USA, Inc.
Microbiology · 20d
Cleared Nov 28, 1989
MOP CATHETER
K891239 · KDL
Bivona Medical Technologies
Gastroenterology & Urology · 266d
Cleared Nov 28, 1989
LATEX PATIENT EXAMINATION GLOVES
K894713 · LYY
Vailwood Products, L.P.
General Hospital · 127d
Cleared Nov 28, 1989
LATEX PATIENT EXAMINATION GLOVES
K894999 · LYY
Pushpaman Processors, Div. Kanjur...
General Hospital · 112d
Cleared Nov 28, 1989
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · CCE
Shiley, Inc.
Anesthesiology · 97d
Cleared Nov 28, 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · CCE
Shiley, Inc.
Anesthesiology · 97d
Cleared Nov 28, 1989
ABBOTT INPERSOL CYCLER 1000
K895336 · FKX
Abbott Laboratories
Gastroenterology & Urology · 89d
Cleared Nov 28, 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20
K895428 · DXN
A&D Engineering, Inc.
Cardiovascular · 84d
Cleared Nov 28, 1989
A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650
K895429 · DXN
A&D Engineering, Inc.
Cardiovascular · 84d
Cleared Nov 28, 1989
HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100
K895430 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 84d
Cleared Nov 28, 1989
STANDARD CONDOM
K895530 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 76d
Cleared Nov 28, 1989
LONE STAR TRADING SURGICAL GLOVE
K896051 · KGO
Lone Star Trading Pte. , Ltd.
General Hospital · 41d
Cleared Nov 28, 1989
BIOBRANE(R) II
K896110 · KGN
Sterling Drug, Inc.
General & Plastic Surgery · 36d