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
103465–103488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · EOB
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 22d
Cleared Apr 07, 1995
INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
K951338 · HLI
Neitz Instruments Company, Ltd.
Ophthalmic · 14d
Cleared Apr 06, 1995
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER
K934975 · DXH
Rlt Medical Assoc., Inc.
Cardiovascular · 535d
Cleared Apr 06, 1995
ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES
K935437 · DRX
Arbo Medical, Inc.
Cardiovascular · 512d
Cleared Apr 06, 1995
BSC/CA MODEL 940 IAB
K940298 · DSP
Boston Scientific Corp
Cardiovascular · 440d
Cleared Apr 06, 1995
QUEST CORONARY SINUS PERFUSION CANNULA -FRCC
K941916 · DWF
Quest Medical, Inc.
Cardiovascular · 352d
Cleared Apr 06, 1995
CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY
K945521 · FOZ
Menlo Care, Inc.
General Hospital · 147d
Cleared Apr 06, 1995
FLEXART(TM) QD C-SPINE COIL
K945665 · LNH
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 06, 1995
MRT-35A UPGRADE 8.0CD
K945798 · LNH
Toshiba America Mri, Inc.
Radiology · 129d
Cleared Apr 06, 1995
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K946105 · GEI
Endoscopic Technologies, Inc.
General & Plastic Surgery · 113d
Cleared Apr 06, 1995
CARBON FIBER COUCH INSERT
K950068 · KXJ
Medtec, Inc.
Radiology · 87d
Cleared Apr 06, 1995
IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
K950140 · DTD
Pacesetter, Inc.
Cardiovascular · 83d
Cleared Apr 06, 1995
TITAN INSUFFLATION NEEDLE
K950243 · GCJ
Endolap, Inc.
General & Plastic Surgery · 76d
Cleared Apr 06, 1995
KSEA STEINER ELECTROMECHANIC MORCELLATOR
K950339 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 69d
Cleared Apr 06, 1995
AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
K950667 · EAP
Chicago X-Ray Systems, Inc.
Radiology · 52d
Cleared Apr 06, 1995
SHARPLAN MODEL 1015 CO2 LASER
K950725 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 49d
Cleared Apr 06, 1995
WELCH ALLYN OTOSCOPE
K950787 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 44d
Cleared Apr 06, 1995
FINESS I (DERMATOLOGIC APPLICATION)
K951032 · GEI
Utah Medical Products, Inc.
General & Plastic Surgery · 31d
Cleared Apr 06, 1995
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · BSK
Rusch Intl.
Anesthesiology · 31d
Cleared Apr 06, 1995
ANGIOREX CAT-350B
K951053 · IZZ
Toshiba America Medical Systems, In.C
Radiology · 30d
Cleared Apr 06, 1995
ENDOBOOT
K951104 · OCU
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 27d
Cleared Apr 06, 1995
SINGLE USE INSTRUMENT TRAY
K951149 · LRO
Medcare Custom Packaging, Inc.
General & Plastic Surgery · 24d
Cleared Apr 06, 1995
FI-10M
K951194 · CAL
Pentax Precision Instrument Corp.
Anesthesiology · 21d
Cleared Apr 06, 1995
FI-10P
K951195 · CAL
Pentax Precision Instrument Corp.
Anesthesiology · 21d