Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
146833–146856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 31, 1985
SAFE.N.SURE
K852620 · HIS
Ashai Co. , Ltd.
Obstetrics & Gynecology · 133d
Cleared Oct 31, 1985
INTERPORE 200 POROUS HYDROXYAPATITE
K852975 · DZC
Inrterpore Intl.
Dental · 108d
Cleared Oct 31, 1985
ILEX PROMPT CLINICAL CHEMISTRY ANALYER
K853068 · CEM
Ilex Corp.
Chemistry · 101d
Cleared Oct 31, 1985
PAXIAL
K853116 · IYO
Biophysic Medical, Inc.
Radiology · 98d
Cleared Oct 31, 1985
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
K853160 · ELM
Austenal Dental, Inc.
Dental · 93d
Cleared Oct 31, 1985
DENTAL CEMENT
K853431 · EBF
Dentsply Intl.
Dental · 77d
Cleared Oct 31, 1985
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · DXK
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Oct 31, 1985
DB PRECISION IMPLANT SYSTEM
K853788 · DZE
Driskell Bioengineering
Dental · 51d
Cleared Oct 31, 1985
THROMBO SCREEN SICKLE CELL ASSAY SET
K854079 · GHM
Pacific Hemostasis
Hematology · 24d
Cleared Oct 31, 1985
MICRO-MAT SYSTEM
K854121 · GKJ
Prevo Micro-Mat System
Hematology · 22d