FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122617–122640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1991
MICRO-VENT NEBULIZER SYSTEM
K904717 · CAF
Tri/Bor Medical, Inc.
Anesthesiology · 165d
Cleared Apr 01, 1991
AERO-GEN NUBULIZER SYSTEM
K904718 · CAF
Tri/Bor Medical, Inc.
Anesthesiology · 165d
Cleared Apr 01, 1991
AMSET PLD SYSTEM
K905014 · HRX
Advanced Med/Surg, Inc.
Orthopedic · 146d
Cleared Apr 01, 1991
TEMPERATURE PROBE
K905148 · CAI
Tec II Medical, Inc.
Anesthesiology · 137d
Cleared Apr 01, 1991
NORMLGEL PROTECTIVE WOUND GEL
K905438 · FRO
Scott Health Care
General & Plastic Surgery · 118d
Cleared Apr 01, 1991
E-Z-EM PULSED INFUSION SYSTEM
K905447 · KRA
E-Z-Em, Inc.
Cardiovascular · 117d
Cleared Apr 01, 1991
RSVP RF-2000
K905586 · KMI
Tactilitics, Inc.
General Hospital · 116d
Cleared Apr 01, 1991
CUTINOVA HYDRO
K905688 · KOZ
Beiersdorf, Inc.
General & Plastic Surgery · 103d
Cleared Apr 01, 1991
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K910083 · HSX
Osteonics Corp.
Orthopedic · 83d
Cleared Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · DQO
Baxter Healthcare Corp
Cardiovascular · 75d
Cleared Apr 01, 1991
KELLER VITAL SIGNS MONITOR - KMS-890
K910262 · DSJ
Keller Medical Specialties Products,...
Cardiovascular · 69d
Cleared Apr 01, 1991
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
K910425 · FRN
Baxter Healthcare Corp
General Hospital · 60d
Cleared Apr 01, 1991
GOOD VIBRATIONS TUBE MASSAGER
K910519 · ISA
Dual Voltage, Inc.
Physical Medicine · 53d
Cleared Apr 01, 1991
BLADES FOR SPINAL LAMINECTOMY RETRACTOR
K910621 · GZT
International Hospital Supply Co.
Neurology · 48d
Cleared Apr 01, 1991
GAUZE SPONGES ABSORBENT GAUZE ROLLS
K910623 · EFQ
Liaoning-Usa Corp.
General & Plastic Surgery · 47d
Cleared Apr 01, 1991
WEEVAC TC HAND CARRIED RESCUE STRETCHER
K910709 · FPP
W. Murphy Ent., Inc.
General Hospital · 40d
Cleared Apr 01, 1991
CLEANFLOW SYSTEM
K910728 · KQT
Mitron Technologies, Inc.
Gastroenterology & Urology · 40d
Cleared Apr 01, 1991
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K910864 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K910865 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
K910866 · DSY
Vascutek, Ltd.
Cardiovascular · 31d
Cleared Apr 01, 1991
PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X
K910897 · GDW
3M Medical Products Group
General & Plastic Surgery · 28d
Cleared Apr 01, 1991
CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
K910906 · FPK
Tri-State Hospital Supply Corp.
General Hospital · 27d
Cleared Apr 01, 1991
CLEARVIEW HCG
K910946 · JHJ
Unipath , Ltd.
Chemistry · 26d