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
110449–110472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1994
COBAS (R) CORE T4 EIA
K932605 · KLI
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jan 24, 1994
COBAS(R) CORE FT4 EIA
K932607 · CEC
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jan 24, 1994
MALE/MALE LUER TRANSFER TUBING
K932780 · CAI
Innovations For Mechanical...
Anesthesiology · 229d
Cleared Jan 24, 1994
DUAL VALVED RESPIRATORY T
K932781 · CAI
Innovations For Mechanical...
Anesthesiology · 229d
Cleared Jan 24, 1994
SOUND SELECTOR FULL-SERVICE AUDIOMETER
K933097 · EWO
Ensoniq Corp.
Ear, Nose, Throat · 214d
Cleared Jan 24, 1994
VENTSTREAM DRUG NEBULIZER
K933535 · CAF
Medic-Aid , Ltd.
Anesthesiology · 187d
Cleared Jan 24, 1994
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K934140 · BTT
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 152d
Cleared Jan 24, 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · DYG
Baxter Healthcare Corp
Cardiovascular · 112d
Cleared Jan 24, 1994
HAND HELD DENTAL X-RAY DEVICE
K934818 · IZL
Dept. of the Army
Radiology · 109d
Cleared Jan 24, 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · MID
Elias U.S.A., Inc.
Immunology · 82d
Cleared Jan 24, 1994
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
K935766 · KIR
Advanced Clinical Diagnostics
Pathology · 80d
Cleared Jan 24, 1994
ULTRAVIOLET LAMPS FOR TANNING
K935854 · LEJ
Cosmedico Light, Inc.
General & Plastic Surgery · 47d
Cleared Jan 24, 1994
NAMTAI
K935872 · DXN
Nam Tai Electronics (Canada) , Ltd.
Cardiovascular · 59d
Cleared Jan 21, 1994
NICO DENTAL ALLOY
K924716 · EJH
Co-Nick Alloys (India) , Ltd.
Dental · 487d
Cleared Jan 21, 1994
AMK LANDMARK REVISION KNEE SYSTEM
K925072 · JWH
Depuy, Inc.
Orthopedic · 471d
Cleared Jan 21, 1994
REPLICA
K925746 · ELW
Matech, Inc.
Dental · 434d
Cleared Jan 21, 1994
ACRYL-X II SYSTEM
K930629 · LZV
Sonokinetics, Inc.
Orthopedic · 347d
Cleared Jan 21, 1994
CP & S STERILE BURN SHEET
K930759 · FPY
Consolidated Products & Services, Inc.
General & Plastic Surgery · 343d
Cleared Jan 21, 1994
CHANNEL-EDGE BRACKET SYSTEM
K930881 · EJF
Dualtek, Inc.
Dental · 367d
Cleared Jan 21, 1994
REBARON LC
K930939 · EBI
GC America, Inc.
Dental · 332d
Cleared Jan 21, 1994
QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE
K931093 · EIA
Dentalez Group
Dental · 324d
Cleared Jan 21, 1994
ISOLAIR 2 FULL FACE SPLASH GUARD
K931288 · LYU
Louis M. Gerson Co., Inc.
General Hospital · 315d
Cleared Jan 21, 1994
KSF SPINAL FIXATOR
K931488
Franklin Medical USA, Inc.
General & Plastic Surgery · 302d
Cleared Jan 21, 1994
ACUFEX PRO-PAC AND ISO-PAC
K931621 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 294d