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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82825–82848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2000
SIGNUM
K001360 · EBF
J.F. Jelenko & Co., Inc.
Dental · 53d
Cleared Jun 20, 2000
AURELUX Y 84 PREMIUM
K001477 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
AURECAST SUPER INLAY
K001478 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
CALCIUM SULFATE PELLETS
K001559 · MQV
Howmedica Osteonics Corp.
Orthopedic · 32d
Cleared Jun 20, 2000
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
K001711 · IYN
Agilent Technologies, Inc.
Radiology · 15d
Cleared Jun 20, 2000
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL...
K001733 · JDI
Zimmer, Inc.
Orthopedic · 13d
Cleared Jun 20, 2000
MEDI-CULT M3 MEDIUM
K991331 · MQL
Medicult A/S
Obstetrics & Gynecology · 428d
Cleared Jun 20, 2000
MEDI-CULT HYALURONIDASE
K991334 · MQL
Medicult A/S
Obstetrics & Gynecology · 428d
Cleared Jun 20, 2000
OCD2001
K992935 · NFB
Contemporary Products, Inc.
Anesthesiology · 294d
Cleared Jun 20, 2000
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
K993125 · FMI
Safety Medical Supply Int,., Inc.
General Hospital · 274d
Cleared Jun 20, 2000
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
K993176 · KGI
Norland Medical Systems, Inc.
Radiology · 272d
Cleared Jun 20, 2000
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K993625 · HIF
Genicon, LC
Obstetrics & Gynecology · 238d
Cleared Jun 19, 2000
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
K000754 · JNB
Quantase , Ltd.
Chemistry · 103d
Cleared Jun 19, 2000
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 98d
Cleared Jun 19, 2000
CALIBRATION SOLUTION 1, MODEL A943-837
K001484 · JIX
Alko Diagnostic Corp.
Chemistry · 39d
Cleared Jun 19, 2000
ADVANTAGE THC TEST
K001567 · LDJ
Advantage Diagnostics Corp.
Toxicology · 31d
Cleared Jun 19, 2000
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632 · JJY
Avl Scientific Corp.
Chemistry · 24d
Cleared Jun 19, 2000
OPAQUE HERRICK PLUG, 0.3MM
K001737 · LZU
Lacrimedics, Inc.
Ophthalmic · 12d
Cleared Jun 19, 2000
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
K994239 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 186d
Cleared Jun 16, 2000
TEARAWAY INTRODUCER SHEATH
K000313 · DYB
Xentek Medical, Inc.
Cardiovascular · 136d
Cleared Jun 16, 2000
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · LKF
Medical Device Technologies, Inc.
Obstetrics & Gynecology · 128d
Cleared Jun 16, 2000
CONTEMPRO-MIST
K000543 · CAF
Contemporary Products, Inc.
Anesthesiology · 119d
Cleared Jun 16, 2000
ABSOLUTE HCG PREGNANCY TEST
K000844 · DHA
Mizuho USA, Inc.
Chemistry · 93d
Cleared Jun 16, 2000
CHAD THERAPEUTICS OXYMATIC MODEL 401
K000890 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 88d