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
108817–108840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1994
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
K940903 · KBM
Medical Insights, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 14, 1994
KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD
K940904 · EFQ
Medical Insights, Inc.
General & Plastic Surgery · 49d
Cleared Apr 14, 1994
DERMASSIST(TM) XEROFORM PETROLATUM DRESSING
K941005 · FRO
Wilshire Medical Products
General & Plastic Surgery · 44d
Cleared Apr 13, 1994
IVALON EMBOLIZATION PARTICLES
K913556 · HCG
Ivalon
Neurology · 978d
Cleared Apr 13, 1994
MOORE SECURE CAP
K931042 · LYU
Kerma Medical Products, Inc.
General Hospital · 408d
Cleared Apr 13, 1994
SURGICLEAN ENZYMATIC INSTRUMENT CLEANER
K931270 · FLG
Surgicot, Inc.
General Hospital · 401d
Cleared Apr 13, 1994
INTRAVASCULAR ADMINISTRATION SET
K932165 · FPA
Mcgaw, Inc.
General Hospital · 344d
Cleared Apr 13, 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · LPH
Depuy, Inc.
Orthopedic · 252d
Cleared Apr 13, 1994
LADY'S CARE MAXI PADS
K933950 · HHD
Lady'S Care, Inc.
Obstetrics & Gynecology · 244d
Cleared Apr 13, 1994
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
K934124 · JQW
Andronic Devices, Ltd.
Chemistry · 231d
Cleared Apr 13, 1994
FILE-EZE
K934415 · KJJ
Ultradent Products, Inc.
Dental · 215d
Cleared Apr 13, 1994
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 198d
Cleared Apr 13, 1994
ICS 9400 ULTRAVIOLET AIR PURIFIER
K934914 · FRA
Medair, Inc.
General Hospital · 182d
Cleared Apr 13, 1994
FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD
K934974 · FXX
Mid America Medical, Inc.
General Hospital · 176d
Cleared Apr 13, 1994
PANTY LINERS
K935562 · HHD
Lady'S Care, Inc.
Obstetrics & Gynecology · 147d
Cleared Apr 13, 1994
NATRACARE MENSTRUAL PADS
K940329 · HHD
Natracare, LLC
Obstetrics & Gynecology · 79d
Cleared Apr 13, 1994
AESCULAP TROCAR COLLAR
K941024 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 40d
Cleared Apr 13, 1994
STRUCTUR 2
K941124 · EBG
Voco GmbH
Dental · 35d
Cleared Apr 12, 1994
LAPAROSCOPY INSTRUMENTS
K931778 · GCJ
Buckman Co., Inc.
General & Plastic Surgery · 368d
Cleared Apr 12, 1994
TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE
K932345 · DWG
Conmedcorp
General & Plastic Surgery · 333d
Cleared Apr 12, 1994
KRONNER REINFORCING STYLETTE
K932432 · LKF
Unimar, Inc.
Obstetrics & Gynecology · 327d
Cleared Apr 12, 1994
SUNGLASSES
K932844 · HQY
Glascal Industries, Ltd.
Ophthalmic · 306d
Cleared Apr 12, 1994
DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS
K933682 · JFJ
Miles, Inc.
Chemistry · 257d
Cleared Apr 12, 1994
CODMAN QUICK SHUNT KIT, CAT. #82-6570
K934196 · GWG
Codman & Shurtleff, Inc.
Neurology · 229d