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
113473–113496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1993
HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.
K925699 · GCJ
Ultracision, Inc.
General & Plastic Surgery · 186d
Cleared May 17, 1993
EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S
K925790 · EYC
Deroyal Industries, Inc.
Gastroenterology & Urology · 182d
Cleared May 17, 1993
MICROSURGE SUCTION/IRRIGATION SYSTEM
K925830 · GEI
Microsurge, Inc.
General & Plastic Surgery · 181d
Cleared May 17, 1993
DMI TOCAR AND CANNULA SYSTEM
K926078 · GCJ
Diversified Medical Instruments, Inc.
General & Plastic Surgery · 167d
Cleared May 17, 1993
UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT
K926341 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 151d
Cleared May 17, 1993
VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E3200
K926414 · GEI
Valleylab, Inc.
General & Plastic Surgery · 145d
Cleared May 17, 1993
525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR
K926554 · KPR
Tingle X-Ray Products, Inc.
Radiology · 137d
Cleared May 17, 1993
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
K930053 · FWF
Medical Devices, Inc.
General & Plastic Surgery · 131d
Cleared May 17, 1993
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
K930105 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 126d
Cleared May 17, 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 115d
Cleared May 17, 1993
A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
K930528 · GEI
Alto Development Corp.
General & Plastic Surgery · 104d
Cleared May 17, 1993
FIGLEAF SHIELD
K930763 · IWT
Byers Industries, Inc.
Radiology · 94d
Cleared May 17, 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · EOB
Storz Instrument Co.
Ear, Nose, Throat · 83d
Cleared May 17, 1993
MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR
K931272 · GCJ
Minimally Invasive Surgical...
General & Plastic Surgery · 70d
Cleared May 14, 1993
NICOLET ULTRASOM ACQUISITION STATION
K921138 · GWQ
Nicolet Instrument Corp.
Neurology · 430d
Cleared May 14, 1993
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
K923868 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 284d
Cleared May 14, 1993
AIA-PACK IGE CALIBRATION VERIFICATION TEST SET
K924859 · JJX
Tosoh Medics, Inc.
Immunology · 228d
Cleared May 14, 1993
VENTREX ALLERGEN DISC
K925044 · DHB
Ventrex, Inc.
Immunology · 221d
Cleared May 14, 1993
TEST THROMBIN
K930157 · GJA
Behring Diagnostics, Inc.
Hematology · 121d
Cleared May 14, 1993
NIGHT URINARY DRAINAGE BEDSIDE BAG
K930556 · EYZ
Ezmt Valve Co., Inc.
Gastroenterology & Urology · 100d
Cleared May 14, 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · DXY
Medtronic Vascular
Cardiovascular · 87d
Cleared May 14, 1993
BARD STABILIZING CANNULA
K930827 · FAJ
C.R. Bard, Inc.
Gastroenterology & Urology · 86d
Cleared May 14, 1993
THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
K931311 · JZO
Nichols Institute
Immunology · 60d
Cleared May 13, 1993
GUIDOR(TM)
K912724 · NPK
Procordia Oratech AB
Dental · 695d