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
125209–125232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1990
CUSTOMED HIP PACT
K903336 · LRO
Customed, Inc.
General & Plastic Surgery · 35d
Cleared Aug 29, 1990
TOPCAST
K903550 · EJT
Argen Precious Metals, Inc.
Dental · 23d
Cleared Aug 29, 1990
ARGIDENT YELLOW 2 GOLD ALLOY FOR PROCELAIN
K903679 · EJT
Argen Precious Metals, Inc.
Dental · 16d
Cleared Aug 29, 1990
ARGILITE 4 GOLD ALLOY FOR PORCELAIN
K903686 · EFT
Argen Precious Metals, Inc.
Dental · 16d
Cleared Aug 29, 1990
FIBER OPTIC LIGHT CABLE
K903800 · FST
Orlux Engineering and Instrumentation
General & Plastic Surgery · 9d
Cleared Aug 28, 1990
SUNGLASSES
K897090 · HQY
Pt Midas Surya Optical Co.
Ophthalmic · 251d
Cleared Aug 28, 1990
THE PRECISIONIST
K900493 · HQC
Paradigm Medical, Inc.
Ophthalmic · 207d
Cleared Aug 28, 1990
VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.
K901066 · DQA
Pace Tech, Inc.
Anesthesiology · 174d
Cleared Aug 28, 1990
ELECTROSTIM MST
K901417 · GZJ
Promatek Industries, Ltd.
Neurology · 155d
Cleared Aug 28, 1990
RADIUS AND SONOCHROME
K902070 · ITX
General Electric Co.
Radiology · 112d
Cleared Aug 28, 1990
COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL
K902392 · EMA
Coltene, Inc.
Dental · 90d
Cleared Aug 28, 1990
CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)
K902460 · IZD
Oakfield Instruments, Ltd.
Radiology · 85d
Cleared Aug 28, 1990
COAXIAL CATHETER SET
K902694 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 70d
Cleared Aug 28, 1990
AUTOMATED HYDROSONICS(TM)
K902798 · HQC
Alcon Surgical, Inc.
Ophthalmic · 62d
Cleared Aug 28, 1990
SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST
K902817 · EMA
Confi-Dental Products Co.
Dental · 62d
Cleared Aug 28, 1990
TOY SUNGLASSES
K903202 · HQY
Creative Design
Ophthalmic · 39d
Cleared Aug 27, 1990
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918 · DEH
Dako Corp.
Hematology · 259d
Cleared Aug 27, 1990
LIFECARE MODEL 4 PUMP
K900467 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 27, 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 27, 1990
YSI MODEL 1500 SPORT L-LACTATE ANALYZER
K901131 · KHP
Yellow Springs Instrument Co., Inc.
Chemistry · 168d
Cleared Aug 27, 1990
UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER
K902585 · KOE
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 27, 1990
DRAPE, SURGICAL - UTILITY DRAPE - STERILE
K903726 · KKX
Graham Medical Products
General Hospital · 11d
Cleared Aug 24, 1990
LUMISCOPE EMS 8000
K901849 · IPF
Lumiscope Co., Inc.
Physical Medicine · 122d
Cleared Aug 24, 1990
MODIFIED AML + ACETABULAR CUP SYSTEM
K902395 · JDI
Depuy, Inc.
Orthopedic · 86d