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
101209–101232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1995
AM-YAG
K950825 · GEX
American Lasers, Inc.
General & Plastic Surgery · 186d
Cleared Aug 28, 1995
LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER
K951018 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 175d
Cleared Aug 28, 1995
TRI-CEN GERMICIDAL DETERGENT
K951020 · LRJ
Central Solutions, Inc.
General Hospital · 174d
Cleared Aug 28, 1995
IMAGYN ENDOSCOPE SHEATH
K951974 · GCJ
Imagyn Medical, Inc.
General & Plastic Surgery · 123d
Cleared Aug 28, 1995
DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
K952336 · LRJ
Caltech Industries, Inc.
General Hospital · 102d
Cleared Aug 28, 1995
CITRACE HOSPITAL GERMICIDAL DEODORIZER
K952405 · LRJ
Caltech Industries, Inc.
General Hospital · 98d
Cleared Aug 28, 1995
CAPNO-FLO REGULATOR, CAPNO-FLO
K952512 · BTM
Kirk Specialty Systems
Anesthesiology · 90d
Cleared Aug 28, 1995
SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM
K952554 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 87d
Cleared Aug 28, 1995
BIO-OSS
K952618 · LYC
Geistlich-Pharma
Dental · 83d
Cleared Aug 28, 1995
BIO-OSS CERAMIC
K952619 · LYC
Geistlich-Pharma
Dental · 83d
Cleared Aug 28, 1995
COMP=FLOW
K952662 · EBF
Jeneric/Pentron, Inc.
Dental · 77d
Cleared Aug 28, 1995
SPIRIT RIDGE NASAL IMPLANT
K952705 · FZE
Spirit Ridge Technologies
General & Plastic Surgery · 75d
Cleared Aug 28, 1995
SPIRIT RIDGE SILICONE CARVING BLOCK
K952706 · FZE
Spirit Ridge Technologies
General & Plastic Surgery · 75d
Cleared Aug 28, 1995
SILICONE ELASTOMER MALAR IMPLANT
K952707 · FZE
Spirit Ridge Technologies
General & Plastic Surgery · 75d
Cleared Aug 28, 1995
PECTORALIS IMPLANT
K952708 · FZE
Spirit Ridge Technologies
General & Plastic Surgery · 75d
Cleared Aug 28, 1995
PROTHESIS, CHIN, INTERNAL
K952709 · FZE
Spirit Ridge Technologies
General & Plastic Surgery · 75d
Cleared Aug 28, 1995
PADLESS ELECTROSURGICAL PENCIL
K952792 · GEI
Lca, Inc.
General & Plastic Surgery · 70d
Cleared Aug 28, 1995
SHIATSU MASTER MASSAGER CUSHION
K952916 · IRO
Kinsei Shiatsu, Inc.
Physical Medicine · 63d
Cleared Aug 28, 1995
QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER)
K952974 · GEX
Microquartz Medical, Inc.
General & Plastic Surgery · 62d
Cleared Aug 28, 1995
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
K952981 · FYD
Utah Medical Products, Inc.
General Hospital · 61d
Cleared Aug 28, 1995
SAFESKIN SUPRA
K952993 · KGO
Safeskin Corp.
General Hospital · 61d
Cleared Aug 28, 1995
SAFESKIN SUPRA
K953015 · KGO
Safeskin Corp.
General Hospital · 60d
Cleared Aug 28, 1995
MINIPIEZON
K953026 · ELC
Electro Medical Systems SA
Dental · 60d
Cleared Aug 28, 1995
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
K953074 · GEX
Luxar Corp.
General & Plastic Surgery · 59d