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
146233–146256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1985
FAP-CATH
K852456 · DQO
Research Medical, Inc.
Cardiovascular · 144d
Cleared Nov 01, 1985
MEDTRONICS MODELS 8320/8322/8329
K852688 · DXY
Medtronic Vascular
Cardiovascular · 129d
Cleared Nov 01, 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748 · DXY
Cordis Corp.
Cardiovascular · 127d
Cleared Nov 01, 1985
STERICOVER
K853044 · IZI
Sterimed, Inc.
Radiology · 105d
Cleared Nov 01, 1985
MALLORY/HEAD TOTAL HIP SYSTEM
K853259 · KMC
Biomet, Inc.
Orthopedic · 91d
Cleared Nov 01, 1985
DUROMEDICS CARDIAC VALVE SIZER SET
K853313 · DTI
Hemex Scientific, Inc.
Cardiovascular · 86d
Cleared Nov 01, 1985
RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000
K853395 · IZH
Raytheon Medical Systems
Radiology · 81d
Cleared Nov 01, 1985
LASER IRAS
K853556 · HPJ
Randwal Instrument Co., Inc.
Ophthalmic · 67d
Cleared Nov 01, 1985
VESSA TREKKA
K853595 · ITI
Vessa , Ltd.
Physical Medicine · 66d
Cleared Nov 01, 1985
PERSONAL AMPLIFIER SLIMLINE III
K853605 · ESD
Electone, Inc.
Ear, Nose, Throat · 65d
Cleared Nov 01, 1985
POLY-SLEEVE
K853631
CooperVision, Inc.
Ophthalmic · 63d
Cleared Nov 01, 1985
FIRST TEMP
K853713 · FLL
Intelligent Medical Systems
General Hospital · 57d
Cleared Nov 01, 1985
MENTOR BRIGHTNESS ACUITY TESTER
K853736 · HOX
Mentor O & O, Inc.
Ophthalmic · 56d
Cleared Nov 01, 1985
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
K853812 · HLX
Biosan Laboratories, Inc.
Ophthalmic · 50d
Cleared Nov 01, 1985
SNAP-LOCK ADDITIVE CAP #SL 200
K854032 · KPE
Williams Medical Co.
General Hospital · 31d
Cleared Nov 01, 1985
PULMANEX
K854037 · BTM
Life Design Systems, Inc.
Anesthesiology · 51d
Cleared Nov 01, 1985
PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD
K854082 · FOX
Gray Wave Corp.
General Hospital · 25d
Cleared Nov 01, 1985
MURRAY CHAIR LIFT
K854120 · FNG
J.B. Murray Enterprises, Inc.
General Hospital · 23d
Cleared Nov 01, 1985
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
K854143 · DXY
Telectronics, Inc.
Cardiovascular · 21d
Cleared Nov 01, 1985
OHMEDA CPU AIR COMPRESSOR MODEL 3350
K854306 · BTI
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 31, 1985
SDL-32 ELECTRONIC LINEAR SCANNER
K850834 · IYO
Shimadzu Corp.
Radiology · 244d
Cleared Oct 31, 1985
UNIVERSAL SERVICE MODULE
K851446 · IYO
Diasonics, Inc.
Radiology · 203d
Cleared Oct 31, 1985
DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM
K851860 · IYO
Diasonics, Inc.
Radiology · 188d
Cleared Oct 31, 1985
UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52
K852362 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 149d