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
107257–107280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1994
LIFE PULSE RESUSCITATION TIMER
K932867 · PMK
Green Field Medical Sourcing, Inc.
Anesthesiology · 406d
Cleared Jul 25, 1994
FREEWAY LITE NEBULIZER COMPRESSOR
K934749 · CAF
Medic-Aid , Ltd.
Anesthesiology · 294d
Cleared Jul 25, 1994
PEDIATRIC DEFIB K-PADS
K935083 · LDD
Katecho, Inc.
Cardiovascular · 273d
Cleared Jul 25, 1994
ARTERIAL EMBOLECTOMY
K935405 · DXE
J-Lloyd Medical, Inc.
Cardiovascular · 258d
Cleared Jul 25, 1994
SUNGLASSES, SPECTACLE FRAMES
K940372 · HQY
Giorgio Nannini Srl
Ophthalmic · 180d
Cleared Jul 25, 1994
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT
K940381 · LRJ
National Laboratories
General Hospital · 180d
Cleared Jul 25, 1994
LYSOL I.C. BRAND DISINFECTANT SPRAY
K940400 · LRJ
L&F Products
General Hospital · 179d
Cleared Jul 25, 1994
SUNGLASSES
K940925 · HQY
Gold Link Design , Ltd.
Ophthalmic · 147d
Cleared Jul 25, 1994
POS-T-VAC-AVP-1000
K941087 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 25, 1994
HAPPY EYES OPTICAL CO. SUNGLASSES
K941581 · HQY
Happy Eye Optical Co.
Ophthalmic · 116d
Cleared Jul 25, 1994
MIRACLE-EAR EAR IMPRESSION MATERIAL
K941859 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 101d
Cleared Jul 25, 1994
SUNGLASSES
K941874 · HQY
The Fair Optical Ent.Co. , Ltd.
Ophthalmic · 98d
Cleared Jul 25, 1994
TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE
K941944 · HET
Tahoe Surgical Instruments P.R., Inc.
Obstetrics & Gynecology · 95d
Cleared Jul 25, 1994
SUNGLASSES
K942001 · HQY
Hung Wai Optical Co.
Ophthalmic · 91d
Cleared Jul 25, 1994
R&D BATTERIES, PART NO. 5025, 5128 AND 5183
K942018 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 25, 1994
SUNGLASSES
K942037 · HQY
Golden Year Supply Co.
Ophthalmic · 88d
Cleared Jul 25, 1994
SUNGLASSES
K942038 · HQY
Golden Year Supply Co.
Ophthalmic · 88d
Cleared Jul 25, 1994
SAM SUNG OPTICAL
K942067 · HQY
Sam Sung Optical
Ophthalmic · 87d
Cleared Jul 25, 1994
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
K942152 · GEX
Candela Laser Corp.
General & Plastic Surgery · 83d
Cleared Jul 25, 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE
K942489 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 61d
Cleared Jul 25, 1994
PHACO KIT
K942515 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
10-0 CASSETTE
K942516 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
10-K CASSETTE
K942517 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
CASSETTE SYSTEM FOR SITE
K942518 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d