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
99457–99480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1996
MEDIASTINAL SILICONE DRAINS
K942709 · GBW
Sil-Med Corp.
General & Plastic Surgery · 575d
Cleared Jan 04, 1996
HOLTER 6000
K950988 · DQK
Omega Medical Services, Inc.
Cardiovascular · 307d
Cleared Jan 04, 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE...
K951978 · LOS
Hewlett-Packard Co.
Cardiovascular · 252d
Cleared Jan 04, 1996
CPR MASK & RELATED FAMILY KITS
K953461 · CBP
Safetec of America, Inc.
Anesthesiology · 164d
Cleared Jan 04, 1996
PATIENT EXAMINATION GLOVES
K953462 · LYY
P.T. Irama Dinamika Latex
General Hospital · 164d
Cleared Jan 04, 1996
MEDTROL DENTAL KIT
K953707 · EKJ
Medtrol, Inc.
Dental · 149d
Cleared Jan 04, 1996
DURASOFT FRESHLOOK UV COLORS
K954603 · LPL
Wesley Jessen Corp.
Ophthalmic · 92d
Cleared Jan 04, 1996
HEARTSTART 911
K954609 · MKJ
Laerdal Medical Corp.
Cardiovascular · 92d
Cleared Jan 04, 1996
STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS
K954720 · LJS
Strato/Infusaid, Inc.
General Hospital · 83d
Cleared Jan 04, 1996
BIO-INTERFACES, INC,. BII-PLAST
K954763 · LYC
Bio-Interfaces, Inc.
Dental · 79d
Cleared Jan 04, 1996
SEALITE FL
K954827 · EBC
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared Jan 04, 1996
PHASE CHANGE DENTAL LUBRICANT
K954991 · EFB
Phase Change
Dental · 65d
Cleared Jan 04, 1996
NIPRO SCALP VEIN SET (DISPOSABL PSV SET)
K955053 · FOZ
Nissho Corp.
General Hospital · 59d
Cleared Jan 04, 1996
SPIRIT MB
K955333 · DYW
Ormco Corp.
Dental · 44d
Cleared Jan 04, 1996
SNOREFREE
K955336 · LRK
Scott Feldman Dds & Norman Shapiro Dds
Dental · 45d
Cleared Jan 04, 1996
OPTILUX 400
K955763 · EBZ
Demetron Research Corp.
Dental · 15d
Cleared Jan 03, 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · GXY
Bio-Logic Systems Corp.
Neurology · 492d
Cleared Jan 03, 1996
CRYO CHECK LOW FIBRINOGEN CONTROL
K951823 · GGN
Precision Biologicals, Inc.
Hematology · 258d
Cleared Jan 03, 1996
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
K952260 · HQD
Stellar Contact Lens, Inc.
Ophthalmic · 233d
Cleared Jan 03, 1996
GE ADVANTAGE DICOM CR REPROCESSING STATION
K955185 · LLZ
GE Medical Systems
Radiology · 51d
Cleared Jan 03, 1996
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
K955442 · HKI
Kowa Optimed, Inc.
Ophthalmic · 36d
Cleared Jan 03, 1996
UNISUN
K955539 · HQY
Steven Chen
Ophthalmic · 29d
Cleared Jan 03, 1996
KMANZ II
K955611 · HQY
Gatorz LLC
Ophthalmic · 26d
Cleared Jan 02, 1996
BALLOON UTERINE STENT
K952527 · KNA
Cook Urological, Inc.
Obstetrics & Gynecology · 215d