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
132025–132048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1989
FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT
K890608 · EMA
Macrochem Corp.
Dental · 70d
Cleared Apr 17, 1989
FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT
K890623 · EMA
Macrochem Corp.
Dental · 69d
Cleared Apr 17, 1989
LIP BUMPER
K890656 · EJF
American Orthodontics
Dental · 68d
Cleared Apr 17, 1989
CLEAN DENT
K890668 · EFT
Lincoln Park Dental Laboratory
Dental · 67d
Cleared Apr 17, 1989
SUTURE REMOVAL KIT
K890729 · LRO
Cypress Medical Products, Ltd.
General & Plastic Surgery · 63d
Cleared Apr 17, 1989
UNIFAST LC
K890829 · EBG
G-C Intl. Corp.
Dental · 55d
Cleared Apr 17, 1989
CENTURY DISOSABLE LATEX GLOVE
K890850 · LYY
Century Force Co. , Ltd.
General Hospital · 55d
Cleared Apr 17, 1989
MODIFIED LABELING FOR POLYDERM WBC(TM)
K890940 · NAD
Laivan Corp.
General & Plastic Surgery · 54d
Cleared Apr 17, 1989
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · NAB
Smith & Nephew United, Inc.
General & Plastic Surgery · 46d
Cleared Apr 17, 1989
T.R.S.: TOOTH REPLACEMENT SYSTEM
K891119 · EGG
Health Technology of America, Inc.
Dental · 46d
Cleared Apr 17, 1989
NEUROFOCAL COLLIMATOR
K891266 · KPS
Siemens Gammasonics, Inc.
Radiology · 40d
Cleared Apr 17, 1989
ORTHODONTIC COTTON ROLL HOLDERS
K891354 · KHR
American Orthodontics
Dental · 38d
Cleared Apr 17, 1989
GK ALLOY
K891390 · EJJ
China Link, Inc.
Dental · 34d
Cleared Apr 17, 1989
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
K891460 · EFQ
Smith & Nephew United, Inc.
General & Plastic Surgery · 33d
Cleared Apr 17, 1989
SURGICAL DRILLS
K891615 · DZE
Implant Innovations International, Inc.
Dental · 28d
Cleared Apr 17, 1989
TITANIUM FORCEPS
K891618 · DZE
Implant Innovations International, Inc.
Dental · 28d
Cleared Apr 17, 1989
BICARBONATE CONCENTRATE POWDER
K891921 · KPO
Haemolyte, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 14, 1989
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
K881329 · HEM
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 380d
Cleared Apr 14, 1989
H&M ANTI-SNORING DEVICE
K882303 · LRK
Hays & Meade, Inc.
Dental · 315d
Cleared Apr 14, 1989
CESIUM 137 SOURCE, MODEL CSM-40
K882449 · IWI
Cis-Us, Inc.
Radiology · 304d
Cleared Apr 14, 1989
ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
K883609 · FRN
Squibb Diagnostics
Radiology · 235d
Cleared Apr 14, 1989
COMFORTRON DENTAL ANESTHESIA APPARATUS
K884586 · LWM
M. D. Products
Dental · 163d
Cleared Apr 14, 1989
APEX 215M MOBILE ANGER CAMERA
K884673 · IYX
Elscint, Inc.
Radiology · 157d
Cleared Apr 14, 1989
BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
K884937 · EEG
Grass-Telefactor Product Group
Dental · 137d