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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
131329–131352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1989
KOTEX SUPER MAXI PADS
K890013 · HHT
Kimberly-Clark Corp.
Obstetrics & Gynecology · 112d
Cleared Apr 25, 1989
NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPER
K890654 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 76d
Cleared Apr 25, 1989
CYTOBRUSH
K890706 · HHT
Laboratoire Ccd C/O Washington...
Obstetrics & Gynecology · 74d
Cleared Apr 25, 1989
ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS
K890712 · EBH
Advantage Dental Products, Inc.
Dental · 71d
Cleared Apr 25, 1989
FRS LITE FLUORIDE RELEASING SEALANT
K890740 · DYH
Ormco Corp.
Dental · 71d
Cleared Apr 25, 1989
PATIENT EXAMINATION GLOVES (NON-STERILE VINYL)
K890851 · LYZ
Daw Shin Industrial Co., Ltd.
General Hospital · 63d
Cleared Apr 25, 1989
BARD HYSTEROSALPINGOGRAPHY CATHETERS
K890869 · HES
C.R. Bard, Inc.
Obstetrics & Gynecology · 63d
Cleared Apr 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891258 · LYY
Aek Rubber Product Sdn. Bhd.
General Hospital · 48d
Cleared Apr 25, 1989
GIGLO PATIENT EXAMINATION GLOVE (LATEX)
K891343 · LYY
Giant Glove Industrial Co., Ltd.
General Hospital · 46d
Cleared Apr 25, 1989
OLIVE BRAND, SILKY TOUCH PATIENT EXAMINATION GLOVE
K891344 · LYY
Uni-Attach, Inc.
General Hospital · 46d
Cleared Apr 25, 1989
TAK, VINYL PATIENT EXAMINATION GLOVES
K891645 · LYZ
Tak Ent., Inc.
General Hospital · 39d
Cleared Apr 25, 1989
TOPLAS VINYL PATIENT EXAMINATION GLOVE
K891646 · LYZ
Toplas Industrial Co., Ltd.
General Hospital · 39d
Cleared Apr 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891704 · LYY
Executive Commodities Exchange Co.
General Hospital · 36d
Cleared Apr 25, 1989
PHASER (SINGLE LINEAR MECHANICAL MASSAGE)
K891871 · ISA
Monad Corp.
Physical Medicine · 29d
Cleared Apr 25, 1989
FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE
K892000 · FAM
Schott Fiber Optics, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 25, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892096 · LYY
Grand Universe Trading Co., Ltd.
General Hospital · 22d
Cleared Apr 25, 1989
PROTEX PATIENT EXAMINATION GLOVES (LATEX)
K892115 · LYY
Pt Nusa Dipa Perdana
General Hospital · 21d
Cleared Apr 25, 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 20d
Cleared Apr 24, 1989
LEUNOMED RFB 5000
K881164 · HCC
Hemodynamics, Inc.
Neurology · 402d
Cleared Apr 24, 1989
REBUILDER BUCKET SYSTEM
K882980 · GZJ
Micromed, Inc.
Neurology · 283d
Cleared Apr 24, 1989
CL UNIVERSAL HIP DEVICE
K885146 · KWI
Lima Intl. Corp.
Orthopedic · 130d
Cleared Apr 24, 1989
USCI 7F GUIDE CATHETER
K890420 · DQO
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Apr 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891267 · LYY
Genie Rubber Products Co.
General Hospital · 45d
Cleared Apr 24, 1989
MOBILIMB CPM SHOULDER UNIT
K891345 · BXB
Toronto Medical Corp.
Physical Medicine · 46d