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
131425–131448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1989
MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES
K884097 · ODC
Circon Acmi
Gastroenterology & Urology · 201d
Cleared Apr 17, 1989
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · ELW
Dentsply Intl.
Dental · 195d
Cleared Apr 17, 1989
APEX 115 NUCLEAR MEDICINE PROCESSOR
K884672 · IYX
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 415 ANGER CAMERA
K884674 · IYX
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 609R ANGER CAMERA
K884675 · IYX
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
K885325 · NAD
Frastec Wound Care Products, Inc.
General & Plastic Surgery · 110d
Cleared Apr 17, 1989
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
K890029 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 103d
Cleared Apr 17, 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · HQE
CooperVision, Inc.
Ophthalmic · 88d
Cleared Apr 17, 1989
BCM-ARC 105 X-RAY MOBILE UNIT
K890306 · IZL
B C Medical , Ltd.
Radiology · 84d
Cleared Apr 17, 1989
MENTOR ANTERIOR SEGMENT VITRECTOR
K890595 · HKP
Mentor O & O, Inc.
Ophthalmic · 70d
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