FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83689–83712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 28, 2000
CAMLOG SCREW IMPLANT SYSTEM
K000099 · DZE
Altatec Biotechnologies
Dental · 15d
Cleared Jan 28, 2000
CAMLOG ROOTFORM IMPLANT SYSTEM
K000100 · DZE
Altatec Biotechnologies
Dental · 15d
Cleared Jan 28, 2000
MAGNA ABUTMENT
K984297 · DZE
Factor, Ii, Inc.
Dental · 423d
Cleared Jan 28, 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340 · MAI
Arthrex, Inc.
Orthopedic · 359d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · LZO
Smith & Nephew, Inc.
Orthopedic · 296d
Cleared Jan 28, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR...
K992273 · MHX
Hewlett-Packard GmbH
Cardiovascular · 205d
Cleared Jan 28, 2000
HENRY SCHEIN SURGICAL MASK
K992604 · FXX
Mitsui Textile Corp.
General Hospital · 178d
Cleared Jan 28, 2000
ADVANCED D-DIMER
K992957 · DAP
Dade Behring, Inc.
Hematology · 148d
Cleared Jan 28, 2000
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON...
K993595 · DZE
Nobel Biocare Uas, Inc.
Dental · 95d
Cleared Jan 28, 2000
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K993667 · DSY
Sulzermedica
Cardiovascular · 88d
Cleared Jan 28, 2000
RIM-FIX, ACETABULAR CUP
K993713 · JDI
Surgical Implants, Inc.
Orthopedic · 86d
Cleared Jan 28, 2000
COAGULATION ELECTRODE, MODEL 2000
K993900 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 73d
Cleared Jan 28, 2000
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064 · LZA
Glove Source, Inc.
General Hospital · 58d
Cleared Jan 28, 2000
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 56d
Cleared Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085 · DHA
Diagnostic Products Corp.
Chemistry · 56d