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
127681–127704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1990
DENTAL ENDODONTIC CEMENT (MODIFICATION)
K894092 · KIF
The Hygenic Corp.
Dental · 216d
Cleared Jan 10, 1990
LATEX EXAMINATION GLOVES
K894376 · LYY
P.T. Haluwiko Pratita
General Hospital · 177d
Cleared Jan 10, 1990
PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH
K894437 · FRG
Clive Craig Co.
General Hospital · 177d
Cleared Jan 10, 1990
INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM
K894477 · EMA
Cosmedent, Inc.
Dental · 176d
Cleared Jan 10, 1990
PATIENT EXAMINATION GLOVES
K895228 · LYY
Ray Intl. Co.
General Hospital · 148d
Cleared Jan 10, 1990
LATEX PATIENT EXAMINATION GLOVES
K895237 · LYY
China Shanghai SI DA Latex & Plastics...
General Hospital · 142d
Cleared Jan 10, 1990
CHARISE CHARLES REAGENT STRIPS
K895282 · JIL
Lee Import Domestic Consulting
Chemistry · 139d
Cleared Jan 10, 1990
NOVA PILLOW
K895477 · IQK
Nova Health Systems, Inc.
Physical Medicine · 121d
Cleared Jan 10, 1990
SANI-PIKS DENTAL HAND INSTRUMENT
K895985 · EKJ
Bison-Lee Co.
Dental · 89d
Cleared Jan 10, 1990
MEDICAL DISPOSABLE BEDDING
K896042 · IQK
Keystone Veterinary Supplies, Inc.
Physical Medicine · 86d
Cleared Jan 10, 1990
MATTRESS COVER FOR MEDICAL PURPOSES
K896043 · KME
Keystone Veterinary Supplies, Inc.
General Hospital · 86d
Cleared Jan 10, 1990
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
K896056 · ESD
Rexton, Inc.
Ear, Nose, Throat · 84d
Cleared Jan 10, 1990
ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)
K896132 · EBF
Ivoclar North America, Inc.
Dental · 79d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-LR
K896246 · JJY
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-HR
K896247 · JJY
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 10, 1990
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
K896339 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 68d
Cleared Jan 10, 1990
ENZYMUN TEST R IGE
K896902 · DHB
Boehringer Mannheim Corp.
Immunology · 33d
Cleared Jan 10, 1990
CN CARE STERILE LATEX EXAMINATION GLOVES
K896944 · LYY
C.N. Technocrats
General Hospital · 28d
Cleared Jan 10, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)
K897145 · DHB
3M Company
Immunology · 14d
Cleared Jan 09, 1990
SPIROTEQ
K894556 · BZG
System Analysis Corp.
Anesthesiology · 173d
Cleared Jan 09, 1990
NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
K894568 · KPQ
Advanced Medical Systems, Inc.
Radiology · 172d
Cleared Jan 09, 1990
VOYAGER PX
K895082 · BYJ
Smith-Perry Corp.
Anesthesiology · 148d
Cleared Jan 09, 1990
TRAUMAFUSE TRACH SHIELD
K895162 · BTO
The Traumafuse Co.
Anesthesiology · 140d
Cleared Jan 09, 1990
ACUFEX INTERFERENCE SCREW, STERILE
K895711 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 106d