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
83161–83184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2000
CERALAS D10 810NM DIODE LASER
K993828 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 81d
Cleared Feb 01, 2000
JE 2000
K993878 · IKN
Jack'S Electrodes
Neurology · 78d
Cleared Feb 01, 2000
INTRASTENT DOUBLESTRUT LD
K993904 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 01, 2000
TAC' PIN
K993910 · JDW
New Deal, S.A.
Orthopedic · 76d
Cleared Feb 01, 2000
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
K993911 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 77d
Cleared Feb 01, 2000
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · DML
Syva Co.
Toxicology · 69d
Cleared Feb 01, 2000
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · JXN
Syva Co.
Toxicology · 69d
Cleared Feb 01, 2000
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · JIR
Diagnostic Chemicals , Ltd.
Chemistry · 64d
Cleared Feb 01, 2000
HARDYDISK CEFACLOR 30MCG
K994046 · JTN
Hardy Diagnostics
Microbiology · 64d
Cleared Feb 01, 2000
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
K994148 · JQC
Implant Innovations, Inc.
Immunology · 55d
Cleared Feb 01, 2000
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K994346 · CHL
Sendx Medical, Inc.
Chemistry · 40d
Cleared Jan 31, 2000
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
K000048 · FMF
Biosurgical Corp.
General Hospital · 24d
Cleared Jan 31, 2000
ULTRASHAPER KERATOME
K990227 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 371d
Cleared Jan 31, 2000
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
K990530 · NAD
The Kendall Company, L.P.
General & Plastic Surgery · 346d
Cleared Jan 31, 2000
ROTARY MASTER
K992648 · EBW
J. Morita USA, Inc.
Dental · 178d
Cleared Jan 31, 2000
BARD UROFORCE BALLOON DILATION CATHETER
K993840 · EZN
C.R. Bard, Inc.
Gastroenterology & Urology · 80d
Cleared Jan 31, 2000
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH...
K993857 · KGO
Ansell Perry
General Hospital · 77d
Cleared Jan 31, 2000
NANMA NON-ADJUSTABLE CONSTRICTION RING
K993906 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 75d
Cleared Jan 31, 2000
NANMA AJUSTABLE CONSTRICTION RING
K993908 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 75d
Cleared Jan 31, 2000
SHARP 9000 PHASED ARRAY BRAIN COIL
K994042 · MOS
Usa Instruments, Inc.
Radiology · 63d
Cleared Jan 31, 2000
PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
K994224 · EBF
Prime Dental Manufacturing, Inc.
Dental · 47d
Cleared Jan 31, 2000
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K994246 · LZA
Omnigrace , Ltd.
General Hospital · 46d
Cleared Jan 31, 2000
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K994354 · LYY
Flexitech Sdn. Bhd.
General Hospital · 39d
Cleared Jan 28, 2000
CAMLOG CYLINDER IMPLANT SYSTEM
K000065 · DZE
Altatec Biotechnologies
Dental · 18d