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
108553–108576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1994
GRANITEC IONOMER RESIN CEMENT
K940546 · EMA
Confi-Dental Products Co.
Dental · 81d
Cleared Apr 29, 1994
ENDOSCOPIC SURGICAL INSTRUMENTS
K940551 · GCJ
Tnco, Inc.
General & Plastic Surgery · 81d
Cleared Apr 29, 1994
DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT
K940599 · EIA
Q. C. Filter, Inc.
Dental · 78d
Cleared Apr 29, 1994
SYBRALOY
K940675 · EJJ
Sybron Dental Specialties, Inc.
Dental · 72d
Cleared Apr 29, 1994
UMBILI-CATH-P
K940871 · FOS
Gesco Intl., Inc.
General Hospital · 63d
Cleared Apr 29, 1994
SPECTACLE FRAMES
K940977 · HQZ
Super Optical, Inc.
Ophthalmic · 59d
Cleared Apr 29, 1994
SUNGLASSES
K940990 · HQY
Jpreynolds Co., Inc.
Ophthalmic · 56d
Cleared Apr 29, 1994
LATEX EXAMINATION GLOVES, POWDER FREE
K941056 · LYY
Pt. Eka Wira Asia
General Hospital · 57d
Cleared Apr 29, 1994
AUROLITE CB
K941067 · EJT
Argen Precious Metals, Inc.
Dental · 52d
Cleared Apr 29, 1994
AURIUM PC16
K941072 · EJT
Argen Precious Metals, Inc.
Dental · 52d
Cleared Apr 29, 1994
SUNGLASSES
K941077 · HQY
Kingsun Optical Ent. Co., Ltd.
Ophthalmic · 52d
Cleared Apr 29, 1994
AURIUM D16
K941097 · EJT
Argen Precious Metals, Inc.
Dental · 53d
Cleared Apr 29, 1994
SG-22 SUNGLASSES
K941138 · HQY
American Bestin Mfg., Inc.
Ophthalmic · 50d
Cleared Apr 29, 1994
BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR
K941276 · GCJ
Springfield Surgical Instruments
General & Plastic Surgery · 43d
Cleared Apr 29, 1994
YUNG HSU OPTICAL WORKS CO
K941297 · HQY
Yung Hsu Optical Works Co.
Ophthalmic · 43d
Cleared Apr 29, 1994
VINYL EXAMINATION GLOVE, POWDER FREE
K941357 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 39d
Cleared Apr 29, 1994
SUNGLASSES
K941695 · HQY
Sun Creations, Inc.
Ophthalmic · 23d
Cleared Apr 28, 1994
MULTIPLE PURPOSE FORCEPS
K924792 · GCJ
Nusurg, Inc.
General & Plastic Surgery · 582d
Cleared Apr 28, 1994
ENDOSCOPE
K925968 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 519d
Cleared Apr 28, 1994
SURGICAL SUTURE PACKAGE INSERTS
K930416 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 457d
Cleared Apr 28, 1994
CADD-TPN(TM) AMBULATORY INFUSION SYSTEM
K931113 · FIH
Pharmacia Deltec, Inc.
Gastroenterology & Urology · 420d
Cleared Apr 28, 1994
MOUNTABLE KNIFE
K931323 · HRX
Esco Medical
Orthopedic · 408d
Cleared Apr 28, 1994
DENTAL SCREW POSTS
K931396 · ELR
Harald Nordin S.A
Dental · 405d
Cleared Apr 28, 1994
ACE 6.5 MM BONE SCREW
K931652 · HWC
Ace Medical Co.
Orthopedic · 388d