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
137305–137328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1987
EUB-410 DIAGNOSTIC ULTRASOUND DEVICE
K871004 · IYO
Hitachi Medical Corp. of America
Radiology · 274d
Cleared Dec 11, 1987
HERPES 1 AND 2 MICROASSAYS
K871420 · GGC
Diamedix Corp.
Microbiology · 247d
Cleared Dec 11, 1987
CUSTOM PROCEDURE TRAYS
K871616 · FMF
Medical Custom Products, Inc.
General Hospital · 228d
Cleared Dec 11, 1987
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
K872125 · CCE
C.R. Bard, Inc.
Anesthesiology · 192d
Cleared Dec 11, 1987
FIBERLASE II ND:YAG LASER FOR PULMONARY USE
K872351 · LLO
Laser Media
Anesthesiology · 177d
Cleared Dec 11, 1987
LOVIEL CONDOM
K872861 · HIS
Lloviel Marketing Corp.
Obstetrics & Gynecology · 143d
Cleared Dec 11, 1987
THERMOWRAP, A/K/A/, THERMAL WRAP
K873254 · IRT
Family Sun Tanning
Physical Medicine · 116d
Cleared Dec 11, 1987
TECNOL COMPRESSION KNEE DRESSING
K873368 · LLK
Tecnol New Jersey Wound Care, Inc.
General Hospital · 112d
Cleared Dec 11, 1987
INSTITUTIONAL BILI LIGHT (IBL)
K873700 · LBI
Physician Engineered Products, Inc.
General Hospital · 88d
Cleared Dec 11, 1987
SAFETY SHIELD SUCTION CATHETER
K873810 · BSY
Ballard Medical Products
Anesthesiology · 84d
Cleared Dec 11, 1987
ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)
K873914 · HPL
Richmond Products, Inc.
Ophthalmic · 77d
Cleared Dec 11, 1987
'E' CUBE AND 'E' PAD
K873916 · HOX
Richmond Products, Inc.
Ophthalmic · 77d
Cleared Dec 11, 1987
IVAC(R) DUAL RATE SET - MODEL C50066
K873938 · FRN
Y
General Hospital · 74d
Cleared Dec 11, 1987
BIOCHEM 8800 CAPNOMETER
K873959 · CCK
Biochem International, Inc.
Anesthesiology · 74d
Cleared Dec 11, 1987
REBUILDER(TM)
K874085 · GZJ
Micromed, Inc.
Neurology · 65d
Cleared Dec 11, 1987
HEARING AID (ALL-IN-THE-EAR)
K874218 · ESD
Audiology & Hearing Aid Clinic
Ear, Nose, Throat · 56d
Cleared Dec 11, 1987
S-10 TELEPHONIC POLYSOMNOGRAPH
K874257 · GYE
Telediagnostic Systems, Inc.
Neurology · 52d
Cleared Dec 11, 1987
ASCENDING VENTILATOR BELLOWS
K874371 · CBK
Draeger Medical, Inc.
Anesthesiology · 46d
Cleared Dec 11, 1987
ACE BONE SCREW NUT
K874669 · HTN
Buckman Co., Inc.
Orthopedic · 28d
Cleared Dec 11, 1987
ACE CORTICAL LAG SCREW
K874672 · HWC
Buckman Co., Inc.
Orthopedic · 28d
Cleared Dec 11, 1987
POST AURICULAR HEARING AID 46PP-PC SUMMIT
K874707 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 24d
Cleared Dec 10, 1987
PLASTER VACUUM, 230V MODEL NO. 4183-161
K873723 · LGH
Martin Medical
Orthopedic · 86d
Cleared Dec 10, 1987
HOT ROD THERMAL MASSAGE ROLLER
K873794 · ISA
American Progressive Products Corp.
Physical Medicine · 84d
Cleared Dec 10, 1987
SONICATOR 720 (MODEL ME720)
K873812 · IMI
Mettler Electronics Corp.
Physical Medicine · 83d