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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122017–122040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1991
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
K910022 · FCM
Medical Marketing Group
Gastroenterology & Urology · 89d
Cleared Apr 02, 1991
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
K910217 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 02, 1991
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
K910285 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 02, 1991
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
K910497 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 02, 1991
HEXIDIS ALCOHOL SWAB
K910735 · LKB
Specialites Septodont
General Hospital · 40d
Cleared Apr 02, 1991
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
K910783 · BWN
Smith & Nephew Equipment Group
General & Plastic Surgery · 36d
Cleared Apr 02, 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 02, 1991
MEDIFIL
K910944 · KGN
Biocore
General & Plastic Surgery · 27d
Cleared Apr 01, 1991
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM
K904208 · JWH
Howmedica Corp.
Orthopedic · 201d
Cleared Apr 01, 1991
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · DYB
Cordis Corp.
Cardiovascular · 182d
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