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
100441–100464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1995
AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM...
K954373 · DYH
American Dental Products, Inc.
Dental · 30d
Cleared Oct 19, 1995
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
K954374 · DYH
American Dental Products, Inc.
Dental · 30d
Cleared Oct 19, 1995
XENON NOPPVA
K954561 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 19, 1995
TRY-IN GEL
K954643 · EMA
Sybron Dental Specialties, Inc.
Dental · 9d
Cleared Oct 18, 1995
GALVANIC SKIN RESPONSE DEVICE
K943101 · GZO
Global Ent.
Neurology · 476d
Cleared Oct 18, 1995
BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
K945983 · KXK
Bebig Trade, Inc.
Radiology · 314d
Cleared Oct 18, 1995
LIHTAN 532 LASER
K951117 · GEX
Buckman Co., Inc.
General & Plastic Surgery · 222d
Cleared Oct 18, 1995
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
K952611 · KCW
Sterex Electrolysis Intl., Ltd.
General & Plastic Surgery · 133d
Cleared Oct 18, 1995
PERCENT OXYGEN SENSOR
K952736 · CCL
Analytical Industries, Inc.
Anesthesiology · 125d
Cleared Oct 18, 1995
CANDELA CRYOSYSTEM CS-5
K953294 · GEH
Candela Laser Corp.
General & Plastic Surgery · 96d
Cleared Oct 18, 1995
LUMISYS DICOM TOOKLIT
K953371 · LMD
Lumisys, Inc.
Radiology · 92d
Cleared Oct 18, 1995
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533 · DQX
Terumo Medical Corp.
Cardiovascular · 83d
Cleared Oct 18, 1995
NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES
K953554 · GWG
Nobles-Lai Engineering, Inc.
Neurology · 82d
Cleared Oct 18, 1995
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
K953602 · LIT
Boston Scientific Corp
Cardiovascular · 77d
Cleared Oct 18, 1995
POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE
K953869 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 82d
Cleared Oct 18, 1995
AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
K953889 · GEI
American Biosurgical, Inc.
General & Plastic Surgery · 62d
Cleared Oct 18, 1995
PHILIPS BV 300 SERIES
K953910 · OXO
Philips Medical Systems North...
Radiology · 58d
Cleared Oct 18, 1995
MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
K954076 · GET
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 49d
Cleared Oct 18, 1995
EASY BREATHING NASAL STRIPS
K954252 · LWF
Corbett Lair, Inc.
Ear, Nose, Throat · 37d
Cleared Oct 18, 1995
XE-LITE
K954263 · FTD
Ophthalmic Technologies, Inc.
General & Plastic Surgery · 36d
Cleared Oct 18, 1995
BLA-800A
K954310 · KPW
Toshiba Medical Systems
Radiology · 33d
Cleared Oct 18, 1995
DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
K954345 · IXW
Doosan Corp.
Radiology · 30d
Cleared Oct 18, 1995
KODAK AUTOMIXER II PLUS
K954484 · IXW
Eastman Kodak Company
Radiology · 21d
Cleared Oct 18, 1995
WIDEX SENSO DIGITAL (PX)
K954526 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 19d