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
109177–109200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1994
PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
K940821 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 31d
Cleared Mar 24, 1994
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
K913468 · LFJ
Cook, Inc.
Gastroenterology & Urology · 962d
Cleared Mar 24, 1994
SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
K925958 · GCJ
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 485d
Cleared Mar 24, 1994
DAVIS+GECK REUSABLE TRTOCARS
K930254 · GCJ
Davis & Geck, Inc.
General & Plastic Surgery · 429d
Cleared Mar 24, 1994
ACTION PATRIOT MANUAL WHEELCHAIR
K930803 · IOR
Invacare Corp.
Physical Medicine · 401d
Cleared Mar 24, 1994
REFLEX HTR
K931879 · GCJ
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 344d
Cleared Mar 24, 1994
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · HRX
Biomet, Inc.
Orthopedic · 275d
Cleared Mar 24, 1994
ACU-E PUNCH
K933516 · LRY
Acuderm, Inc.
General & Plastic Surgery · 247d
Cleared Mar 24, 1994
ACUMED CARPAL TUNNEL RELEASE KIT
K933638 · HRX
Acu Med, Inc.
Orthopedic · 240d
Cleared Mar 24, 1994
PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES
K933879 · HHD
Universal Health Care Products...
Obstetrics & Gynecology · 227d
Cleared Mar 24, 1994
STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER
K934175 · BXB
Orthopedic Development, Inc.
Physical Medicine · 210d
Cleared Mar 24, 1994
ARTHROTEK CANNULA SYSTEM
K934401 · HRX
Biomet, Inc.
Orthopedic · 196d
Cleared Mar 24, 1994
COOL LASER OPTICS (CLO) UNIT
K934486 · GEX
Cyruschess
General & Plastic Surgery · 192d
Cleared Mar 24, 1994
SUNGLASSES (NON-PERSCRIPTION)
K934567 · HQY
Jaan Huey Co., Ltd.
Ophthalmic · 189d
Cleared Mar 24, 1994
STRETCHPOWER
K935188 · BXB
Orthopedic Development, Inc.
Physical Medicine · 149d
Cleared Mar 24, 1994
JAW SPREADER
K936050 · KBW
Gam Industries, Inc.
Ear, Nose, Throat · 94d
Cleared Mar 24, 1994
ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
K936257 · EOB
Mitsubishi Cable America, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 24, 1994
OTOSONIC MINI PAS
K940104 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 73d
Cleared Mar 24, 1994
UNIVERSAL CUSHIONED METAL EYE SHIELD
K940213 · HOY
P.J. Products, Inc.
Ophthalmic · 69d
Cleared Mar 24, 1994
BEI MEDICAL SYSTEMS' SMOKE EVACUATOR
K940266 · FYD
Bei Medical Systems Co., Inc.
General Hospital · 62d
Cleared Mar 24, 1994
UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD
K940275 · HOY
P.J. Products, Inc.
Ophthalmic · 62d
Cleared Mar 24, 1994
ORVIS RIVER GUIDE GLASSES
K940292 · HQY
The Orvis Co., Inc.
Ophthalmic · 62d
Cleared Mar 24, 1994
ORVIS MARQUESAS FISHING GLASSES
K940354 · HQY
The Orvis Co., Inc.
Ophthalmic · 58d
Cleared Mar 23, 1994
HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM
K925111 · GWN
Eye Dynamics, Inc.
Neurology · 530d