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
85321–85344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1999
GYRUS ENDOUROLOGY SYSTEM
K990628 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 124d
Cleared Jun 29, 1999
SHADOW TRAYS
K991107 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 89d
Cleared Jun 29, 1999
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K991118 · HEB
Personal Products Co.
Obstetrics & Gynecology · 89d
Cleared Jun 29, 1999
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23,...
K991229 · MQG
Henning Knudsen Engineering A/S
Obstetrics & Gynecology · 78d
Cleared Jun 29, 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
K991287 · FRO
Advanced Medical Solutions Group Plc
General & Plastic Surgery · 76d
Cleared Jun 29, 1999
COAGULOOP
K991314 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 74d
Cleared Jun 29, 1999
OMNI-FIX, HUMERAL NAIL
K991405 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 68d
Cleared Jun 29, 1999
ORIBRUSH - STANDARD - B002
K991593 · HHT
Orifice Medical AB
Obstetrics & Gynecology · 53d
Cleared Jun 29, 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595 · HHT
Orifice Medical AB
Obstetrics & Gynecology · 53d
Cleared Jun 29, 1999
GRIT BLASTED HUMERAL STEM
K991603 · KWT
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 29, 1999
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX...
K991780 · HQD
G.T. Laboratories, Inc.
Ophthalmic · 35d
Cleared Jun 29, 1999
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
K991781 · HQD
G.T. Laboratories, Inc.
Ophthalmic · 35d
Cleared Jun 29, 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952 · LZO
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Jun 29, 1999
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55...
K992010 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 14d
Cleared Jun 28, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
K984162 · MAH
Nobelpharma USA, Inc.
Ear, Nose, Throat · 221d
Cleared Jun 28, 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057 · MNI
Interpore Cross Intl.
Orthopedic · 172d
Cleared Jun 28, 1999
BIONIKE AQ BARBITURATE TEST
K990280 · DIS
Bionike, Inc.
Toxicology · 151d
Cleared Jun 28, 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL...
K990705 · DYB
Medamicus, Inc.
Cardiovascular · 116d
Cleared Jun 28, 1999
POLYSLIT IFE KIT
K990998 · CFF
Helena Laboratories
Immunology · 95d
Cleared Jun 28, 1999
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
K991000 · LPL
Wesley Jessen Corp.
Ophthalmic · 96d
Cleared Jun 28, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991061 · NAE
Dermaphylyx, Inc.
General & Plastic Surgery · 90d
Cleared Jun 28, 1999
THE ACME MEDICAL AESTHETIC ND:YAG LASER
K991234 · GEX
Acme Medical, Inc.
General & Plastic Surgery · 77d
Cleared Jun 28, 1999
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · JDI
Biomet, Inc.
Orthopedic · 14d
Cleared Jun 27, 1999
OVERLANDER PEV 2000
K983497 · ITI
Raye'S, Inc.
Physical Medicine · 265d