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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104137–104160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1995
DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
K946030 · MGQ
Wilshire Medical Products
General & Plastic Surgery · 80d
Cleared Feb 27, 1995
DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING
K946031 · MGQ
Wilshire Medical Products
General & Plastic Surgery · 80d
Cleared Feb 27, 1995
WEE BAG O'MERCURY
K946194 · LCC
Microsurgical Technology, Inc.
Ophthalmic · 69d
Cleared Feb 27, 1995
JAI POWDERFREE LATEX EXAMINATION GLOVES
K946203 · LYY
Intl. Trade Management Co.
General Hospital · 68d
Cleared Feb 27, 1995
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
K950092 · FCM
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 48d
Cleared Feb 27, 1995
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
K950109 · FCM
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 47d
Cleared Feb 27, 1995
OPHTHALMIC SPONGES
K950241 · HOZ
Oasis Medical, Inc.
Ophthalmic · 38d
Cleared Feb 27, 1995
CHAMPRO/UNITED ATHLETIC
K950252 · HQY
Wilson Hunt Intl./, Ltd.
Ophthalmic · 35d
Cleared Feb 27, 1995
KARL STORZ TELE-SCRUB
K950334 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 27, 1995
FOSSIL PARTNERS, L.P. (FOSSIL)
K950374 · HQY
Strasburger & Price, L.L.P.
Ophthalmic · 27d
Cleared Feb 27, 1995
OTICON/LOGIC
K950381 · ESD
Oticon, Inc.
Ear, Nose, Throat · 27d
Cleared Feb 27, 1995
KARL STORZ VISCOUS FLUID INJECTION SET
K950603 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 18d
Cleared Feb 27, 1995
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 14d
Cleared Feb 24, 1995
CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
K921597 · FJK
Haemotronic, Inc.
Gastroenterology & Urology · 1057d
Cleared Feb 24, 1995
EKG VEST
K932903 · DRX
Cardiotronics, Inc.
Cardiovascular · 618d
Cleared Feb 24, 1995
SILICORE SEMI-FLOATER
K934787 · LDF
Electro-Catheter Corp.
Cardiovascular · 507d
Cleared Feb 24, 1995
COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)
K936295 · LYY
Wembley Rubber Products
General Hospital · 424d
Cleared Feb 24, 1995
I.D. AND SEAKEM GTG AGAROSES
K940037 · JZR
Fmc Corp.
Chemistry · 416d
Cleared Feb 24, 1995
FOCUS EMG
K940050 · HCC
Fasstech
Neurology · 415d
Cleared Feb 24, 1995
IKAROS
K940240 · LNJ
Metasystems GmbH
Pathology · 401d
Cleared Feb 24, 1995
FLUOROPLUA CARDIAC AND/OR INSTAVIEW
K941917 · JAA
Fidelity Medical, Inc.
Radiology · 311d
Cleared Feb 24, 1995
SUNGLASSES
K942020 · HQY
Hopper Radio Corp.
Ophthalmic · 304d
Cleared Feb 24, 1995
4003 AEROLITE
K942208 · CAF
Medical Industries America, Inc.
Anesthesiology · 295d
Cleared Feb 24, 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454 · DSP
Datascope Corp.
Cardiovascular · 277d