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
132361–132384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1989
MODEL ESP-200 MAMMOGRAPHIC SYSTEM
K884345 · IZH
Acoma Medical Imaging, Inc.
Radiology · 160d
Cleared Mar 23, 1989
BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
K884849 · HCC
Moe
Neurology · 125d
Cleared Mar 23, 1989
IMS-3 PICTURE ARCHIVING SYSTEM
K884990 · LMB
The Biomedical Engineering Center
Radiology · 112d
Cleared Mar 23, 1989
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
K885316 · KXO
Hewlett-Packard Co.
Obstetrics & Gynecology · 84d
Cleared Mar 23, 1989
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
K890062 · FRN
Pharmacia Deltec, Inc.
General Hospital · 73d
Cleared Mar 23, 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147 · IPF
Rich-Mar Corp.
Physical Medicine · 69d
Cleared Mar 23, 1989
TECHNOMED PULSOLITH LASER SYSTEM
K890436 · FFK
Teknomed, Inc.
Gastroenterology & Urology · 55d
Cleared Mar 23, 1989
PTI - LATEX EXAMINATION GLOVES
K890456 · LYY
Precision Trading Intl., Inc.
General Hospital · 52d
Cleared Mar 23, 1989
NU-DERM HYDROCOLLOID DRESSING
K890545 · FRO
Johnson & Johnson Patient Care, Inc.
General & Plastic Surgery · 48d
Cleared Mar 23, 1989
STANDING DANI WHEELSTAND
K890602 · IPL
Davis Positioning Systems, Inc.
Physical Medicine · 45d
Cleared Mar 23, 1989
UNSTERILE PATIENT EXAMINATION GLOVE
K890627 · LYY
Aladan Corp.
General Hospital · 43d
Cleared Mar 23, 1989
NE-CHECK
K890767 · JPK
Streck Laboratories, Inc.
Hematology · 36d
Cleared Mar 23, 1989
REHABOT-YM
K890838 · BXB
Imex Health, Inc.
Physical Medicine · 30d
Cleared Mar 23, 1989
LATEX EXAMINATION GLOVES
K890847 · LYY
Prime Merit Intl. Corp.
General Hospital · 30d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (STERILE & NON-STERILE)
K890857 · LYY
Health & Hospital Intl.
General Hospital · 30d
Cleared Mar 23, 1989
ATS DOBELL & O'CONNOR'S IODINE
K890861 · JTS
Alpha-Tec Systems, Inc.
Pathology · 30d
Cleared Mar 23, 1989
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K890881 · GWQ
Teca, Inc.
Neurology · 30d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVE, VINYL
K891067 · LYZ
Sun Flower Gloves Co., Ltd.
General Hospital · 22d
Cleared Mar 23, 1989
GRAND COOLING MACHINE
K891152 · ILO
Kinetic Concepts, Inc.
Physical Medicine · 20d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891170 · LYY
Ching Pax Trading Co., Ltd.
General Hospital · 17d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891181 · LYY
Behn Meyer & Co. (M) Sdn Bhd
General Hospital · 17d
Cleared Mar 23, 1989
LATEX EXAMINATION GLOVES
K891206 · LYY
Charug Fang Ent.
General Hospital · 17d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891443 · LYY
Sukas Sdn Bhd
General Hospital · 8d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891446 · LYY
Felda Rubber Corp.
General Hospital · 8d