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
84337–84360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1999
REFERENCE
K992966 · EBF
Espe Dental AG
Dental · 35d
Cleared Oct 07, 1999
BAHO AUTOCLAVABLE CYSTOSCOPE
K992983 · FAJ
Innovative Endoscopy Components, LLC
Gastroenterology & Urology · 34d
Cleared Oct 07, 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038 · JAA
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Oct 06, 1999
SERAQUEST EB VAC IGM
K990977 · LJN
Quest Intl., Inc.
Microbiology · 197d
Cleared Oct 06, 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE,...
K991474 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 162d
Cleared Oct 06, 1999
SUPER SOOTHER
K991914 · FLL
Mart Tiller Corp.
General Hospital · 121d
Cleared Oct 06, 1999
MODIFICATION TO IMX HOMOCYSTEINE
K992274 · LPS
Axis Biochemicals, Asa
Chemistry · 92d
Cleared Oct 06, 1999
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
K992685 · MVO
Phamatech
Toxicology · 57d
Cleared Oct 06, 1999
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K992861 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 42d
Cleared Oct 06, 1999
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992922 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 37d
Cleared Oct 06, 1999
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · EBI
Dentsply Intl.
Dental · 34d
Cleared Oct 06, 1999
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · JDS
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 06, 1999
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K993064 · KDI
Gambro Renal Care Products
Gastroenterology & Urology · 23d
Cleared Oct 06, 1999
REDI-SCREEN
K993100 · DJC
Redwood Biotech, Inc.
Toxicology · 20d
Cleared Oct 05, 1999
PREFERENCE TREATMENT SYSTEM
K983793 · LNH
Northwest Medical Physics Equipment,...
Radiology · 343d
Cleared Oct 05, 1999
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
K990324 · HRX
Nuvasive, Inc.
Orthopedic · 245d
Cleared Oct 05, 1999
DYONICS VARICOSE VEIN ABLATION BLADE
K990723 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 214d
Cleared Oct 05, 1999
V.T.S., INC. (V.T.-3)
K992442 · LKY
Vts, Inc.
Gastroenterology & Urology · 75d
Cleared Oct 05, 1999
CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
K992460 · GEI
Starion Instruments
General & Plastic Surgery · 74d
Cleared Oct 05, 1999
MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010
K992714 · GEI
Hysterx, Inc.
General & Plastic Surgery · 54d
Cleared Oct 05, 1999
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
K992782 · HRX
Nuvasive, Inc.
Orthopedic · 47d
Cleared Oct 05, 1999
MINI-PORT
K992904 · GBW
Taut, Inc.
General & Plastic Surgery · 36d
Cleared Oct 05, 1999
INTRADUCER
K992907 · GBW
Taut, Inc.
General & Plastic Surgery · 36d
Cleared Oct 05, 1999
DEXIDE BIPOLAR FORCEPS II** DEVICE
K993055 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 22d