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
128401–128424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1989
CMS VRB-1200
K895076 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 81d
Cleared Nov 03, 1989
SURGICAL MASK/DENTAL MASK
K895077 · FXX
Ashton Medical Products, Inc.
General Hospital · 81d
Cleared Nov 03, 1989
ECHO GEL (RAINFOREST)
K895100 · ITX
Lead-Lok, Inc.
Radiology · 80d
Cleared Nov 03, 1989
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
K895226 · KWS
3M Company
Orthopedic · 81d
Cleared Nov 03, 1989
X-RAY DETECTABLE GAUZE SPONGE
K895372 · GDY
Keilei Intl., Inc.
General & Plastic Surgery · 66d
Cleared Nov 03, 1989
SAFE-T-CAP
K895432 · FMI
Ausmedics Pty , Ltd.
General Hospital · 56d
Cleared Nov 03, 1989
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · KGO
Safeskin Corp.
General Hospital · 45d
Cleared Nov 03, 1989
KDR ACETABULAR COMPONENT
K895702 · LWJ
Osteonics Corp.
Orthopedic · 42d
Cleared Nov 03, 1989
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834 · DRX
Marquette Electronics, Inc.
Cardiovascular · 32d
Cleared Nov 03, 1989
PALESTRANT IRRIGATION AND DRAINAGE SET
K896087 · KGZ
North American Instrument Corp.
General & Plastic Surgery · 15d
Cleared Nov 03, 1989
EYE PATCH
K896171 · HOY
Eye Garter Company, Inc.
Ophthalmic · 9d
Cleared Nov 03, 1989
STRAPPED EYE SHIELD
K896172 · HOY
Eye Garter Company, Inc.
Ophthalmic · 9d
Cleared Nov 02, 1989
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K894292 · FRN
C.R. Bard, Inc.
General Hospital · 132d
Cleared Nov 02, 1989
BACTERIAL FILTER
K894978 · CAH
Med-Tek Corp.
General Hospital · 91d
Cleared Nov 02, 1989
BIO-CAL 370 HEATER/COOLER
K894980 · DWJ
Bio Medicus, Inc.
Cardiovascular · 86d
Cleared Nov 02, 1989
MODIFIED POSICAM SYSTEM MODEL 6.5
K894998 · KPS
Positron
Radiology · 86d
Cleared Nov 02, 1989
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · BZG
Welch Allyn, Inc.
Anesthesiology · 73d
Cleared Nov 02, 1989
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K895342 · LZU
Lacrimedics, Inc.
Ophthalmic · 63d
Cleared Nov 02, 1989
PUPIL PATHWAY ANALYZER (PPA)
K895609 · HLG
Pulse Medical Instruments
Ophthalmic · 45d
Cleared Nov 02, 1989
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
K895819 · KMF
Medi-Tech, Inc.
General & Plastic Surgery · 34d
Cleared Nov 02, 1989
ALCON SURGICAL SPONGE
K896004 · HOZ
Alcon Laboratories
Ophthalmic · 20d
Cleared Nov 02, 1989
MICROSPEARS
K896084 · HOZ
Sparta Surgical Corp.
Ophthalmic · 14d
Cleared Nov 01, 1989
BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES
K892641 · DTZ
Bard Cardiosurgery Div
Cardiovascular · 203d
Cleared Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · FOZ
Critikon Company, LLC
General Hospital · 174d