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
97993–98016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1996
DMR/CO2 COMBO KTI
K960468 · BTM
Nellcor Puritan Bennett, Inc.
Anesthesiology · 85d
Cleared Apr 26, 1996
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
K960475 · GEX
Luxar Corp.
General & Plastic Surgery · 85d
Cleared Apr 26, 1996
NEO 2 LINE SUCTION SYSTEM
K960488 · BSY
Alcove Medical, Inc.
Anesthesiology · 85d
Cleared Apr 26, 1996
SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER
K960521 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 81d
Cleared Apr 26, 1996
AH PLUS ROOT CANAL SEALER
K960548 · KIF
Dentsply Intl.
Dental · 78d
Cleared Apr 26, 1996
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
K960561 · CFT
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Apr 26, 1996
GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005
K960562 · GCJ
Conmedcorp
General & Plastic Surgery · 77d
Cleared Apr 26, 1996
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
K960572 · LJT
Arrow Intl., Inc.
General Hospital · 79d
Cleared Apr 26, 1996
WOUND CARE COMPRESSION SYSTEM (WCCS)
K960585 · MCY
Suncoast Medical Products, Inc.
General & Plastic Surgery · 74d
Cleared Apr 26, 1996
LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND...
K960594 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS
K960595 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE
K960596 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE
K960597 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
CONCORD MARYLAND BRIDGE CEMENT
K960598 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
SUPERIOR PHOTOCURING HYBRID COMPOSITE
K960599 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS
K960600 · EBF
Dent Zar, Inc.
Dental · 74d
Cleared Apr 26, 1996
ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)
K960729 · EBF
Dent Zar, Inc.
Dental · 64d
Cleared Apr 26, 1996
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K960823 · KLE
Dentsply Intl.
Dental · 57d
Cleared Apr 26, 1996
MODEL 1210, MEDIUM E-NET
K960873 · GXY
Physiometrix, Inc.
Neurology · 53d
Cleared Apr 26, 1996
MODEL 1240, SMALL E NET
K960885 · GXY
Physiometrix, Inc.
Neurology · 53d
Cleared Apr 26, 1996
MM 324
K961076 · EFB
Micro-Mega Societe Anonyme
Dental · 39d
Cleared Apr 26, 1996
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · JTW
Difco Laboratories, Inc.
Microbiology · 36d
Cleared Apr 26, 1996
AVL OPTI 1 PH/BLOOD GAS ANALYZER
K961161 · CHL
Avl Scientific Corp.
Chemistry · 35d
Cleared Apr 26, 1996
IRRIGATION SYSTEM
K961192 · ERL
Linvatec Corp.
Ear, Nose, Throat · 31d