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
121081–121104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1991
INTERVASCULAR ADMINSTRATION SET
K911753 · FPA
Mcgaw, Inc.
General Hospital · 67d
Cleared Jun 24, 1991
MONARCH STERILIZATION CONTAINER SYST, MODIFICATION
K911760 · FRG
Monarch Products, Inc.
General Hospital · 73d
Cleared Jun 24, 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780 · BZD
Ackrad Laboratories
Anesthesiology · 63d
Cleared Jun 24, 1991
INTERLINK(TM) BLUNT CANNULA, MODIFICATION
K911868 · FPA
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 24, 1991
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
K912044 · HIF
Multigon Industries, Inc.
Obstetrics & Gynecology · 47d
Cleared Jun 24, 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · EKJ
Premier Dental Products Co.
Dental · 40d
Cleared Jun 24, 1991
SX90 (TM),MODEL 4800S
K912348 · GZJ
Medical Devices, Inc.
Neurology · 27d
Cleared Jun 24, 1991
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
K912458 · FRN
Medtronic Minimed
General Hospital · 31d
Cleared Jun 24, 1991
BIPOLAR FORCEPS
K912544 · MAV
Everest Medical Corp.
Cardiovascular · 14d
Cleared Jun 21, 1991
LYME IGM ELISA TEST
K903013 · LSR
Gull Laboratories, Inc.
Microbiology · 345d
Cleared Jun 21, 1991
SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
K904239 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 281d
Cleared Jun 21, 1991
EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR
K904298 · DXN
Medi-Swiss Corp.
Cardiovascular · 275d
Cleared Jun 21, 1991
AGFA DIAGNOSTIC CENTER (ADC)
K904519 · LLZ
Enhanced Imaging Technologies, Inc.
Radiology · 261d
Cleared Jun 21, 1991
NDI MODEL IRS-TD
K904676 · KPR
National Diagnostic Imaging, Inc.
Radiology · 252d
Cleared Jun 21, 1991
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
K905074 · IYX
Siemens Gammasonics, Inc.
Radiology · 224d
Cleared Jun 21, 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · LYK
Baxter Healthcare Corp
Cardiovascular · 220d
Cleared Jun 21, 1991
BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
K905518 · IZI
Venusa , Ltd.
Radiology · 196d
Cleared Jun 21, 1991
AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
K905526 · GZJ
Agar Ginosar Electronics
Neurology · 193d
Cleared Jun 21, 1991
FIXATION DEVICES AND BONE PLATE
K910175 · HRS
Micro Surgical Instruments Corp.
Orthopedic · 157d
Cleared Jun 21, 1991
PCA MTK II TOTAL KNEE SYSTEM
K910235 · JWH
Howmedica Corp.
Orthopedic · 154d
Cleared Jun 21, 1991
BIOCLONE'S ELEGANCE IGE ELISA KIT
K910419 · DGC
Bioclone Australia Pty , Ltd.
Immunology · 142d
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 129d
Cleared Jun 21, 1991
MEHIGAN-PILLING PHLEBETOME TM
K911100 · MGZ
Pilling Co.
Cardiovascular · 101d
Cleared Jun 21, 1991
RIGID ENDOSCOPE
K911348 · LNH
Bruel & Kjaer
Radiology · 86d