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
139441–139464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1987
KRONNER COLLES-FOREARM EXTERNAL FIXATION
K871248 · KTT
Kronner Medical
Orthopedic · 65d
Cleared Jun 03, 1987
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
K871397 · CHL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jun 03, 1987
25MM PEYMAN WIDE FIELD YAG LASER LENS
K871450 · HJK
Ocular Instruments, Inc.
Ophthalmic · 51d
Cleared Jun 03, 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 49d
Cleared Jun 03, 1987
VOROSCOPE(TM)
K871735 · HLJ
Australian Biomedical Corporation , Ltd.
Ophthalmic · 29d
Cleared Jun 03, 1987
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
K871772 · JWH
Howmedica Corp.
Orthopedic · 28d
Cleared Jun 03, 1987
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
K871781 · CFJ
Biochemical Trade, Inc.
Chemistry · 28d
Cleared Jun 03, 1987
THE URIC ACID REAGENT SET
K871902 · KNK
Macomb Biotechnology, Inc.
Chemistry · 19d
Cleared Jun 03, 1987
T P C (TONOMETER PROBE COVER)
K871935 · HKX
Krb Ent.
Ophthalmic · 15d
Cleared Jun 03, 1987
D.A.T. (TM) AMYLASE REAGENT
K871943 · CIJ
Behring Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 03, 1987
MULTIPLE SPECTACLE LENS
K871961 · HQG
Korea Asahi Optical Co., Ltd.
Ophthalmic · 14d
Cleared Jun 02, 1987
INTRAUTERINE HEMOSTASIS BALLOON STENT
K863439 · KNA
Mentor Corp.
Obstetrics & Gynecology · 270d
Cleared Jun 02, 1987
ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
K863815 · QGH
Elcot, Inc.
Neurology · 245d
Cleared Jun 02, 1987
POET OXIMETER
K864745 · DQE
Criticare Systems, Inc.
Cardiovascular · 179d
Cleared Jun 02, 1987
CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.
K870411 · DQY
Medical Surgical Concepts, Inc.
Cardiovascular · 119d
Cleared Jun 02, 1987
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
K871125 · GZJ
Biomedical Life Systems, Inc.
Neurology · 74d
Cleared Jun 02, 1987
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
K871126 · GZJ
Biomedical Life Systems, Inc.
Neurology · 74d
Cleared Jun 02, 1987
HEALTH CONCEPTS CONDUCTIVE MEMBRANE
K871292 · GXY
Health Concepts, Inc.
Neurology · 63d
Cleared Jun 02, 1987
KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
K871501 · LRR
Fraass Survival Systems, Inc.
General & Plastic Surgery · 46d
Cleared Jun 02, 1987
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · JWH
Osteonics Corp.
Orthopedic · 27d
Cleared Jun 02, 1987
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 7d
Cleared Jun 01, 1987
KDI QUIK TEST(TM) MARIJUANA SCREEN
K870197 · LDJ
Keystone Diagnostics, Inc.
Toxicology · 132d
Cleared Jun 01, 1987
PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)
K870413 · DRE
Medical Surgical Concepts, Inc.
Cardiovascular · 118d
Cleared Jun 01, 1987
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746 · JFJ
Stanbio Laboratory
Chemistry · 96d