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
147241–147264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1985
SAFE-N-JECT
K852304 · FMF
Gerstner Intl. Trade
General Hospital · 114d
Cleared Sep 20, 1985
PHARMA-PLAST NEEDLE
K852442 · FMI
Pharma-Plast USA, Inc.
General Hospital · 102d
Cleared Sep 20, 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · DXK
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Sep 20, 1985
MIC-CONCEPT SYSTEM
K852613 · LTW
Microtech Medical Systems, Inc.
Microbiology · 93d
Cleared Sep 20, 1985
IDECAP DIALYZER
K852764 · FJH
Trans-National Trade Development Corp.
Gastroenterology & Urology · 84d
Cleared Sep 20, 1985
STERILE DISPOSABLE SYRINGE(3 PIECES)
K852819 · FMF
Fabersanitas, S.A.
General Hospital · 81d
Cleared Sep 20, 1985
VIAL DECANTER
K852893 · KPE
Advance Medical Designs, Inc.
General Hospital · 73d
Cleared Sep 20, 1985
PAO VALUE
K852990 · FMF
Ackard Laboratories
General Hospital · 67d
Cleared Sep 20, 1985
N.K. PEDIATRIC CRIBS
K853355 · FMS
N.K. Medical Products, Inc.
General Hospital · 39d
Cleared Sep 20, 1985
SAFTI-BRACELET
K853418 · KMK
Advanced Biosearch Assn.
General Hospital · 37d
Cleared Sep 20, 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 25d
Cleared Sep 19, 1985
KM-2 METAL-BACKED ACETABULAR CUP
K844319 · JDI
Kirschner Medical Corp.
Orthopedic · 317d
Cleared Sep 19, 1985
MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
K850761 · BZN
Medicor USA , Ltd.
Radiology · 206d
Cleared Sep 19, 1985
RT2600(115V)(220/240V) #H4008A & H4008AE
K851807 · IYO
General Electric Co.
Radiology · 142d
Cleared Sep 19, 1985
IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
K851828 · MOT
Syncor Intl. Corp.
Radiology · 146d
Cleared Sep 19, 1985
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
K852487 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 100d
Cleared Sep 19, 1985
5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517
K852570 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Sep 19, 1985
3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509
K852571 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Sep 19, 1985
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
K852572 · JAF
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Sep 19, 1985
FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)
K852606 · FPA
Infarkem Corp.
General Hospital · 92d
Cleared Sep 19, 1985
FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY
K852696 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 85d
Cleared Sep 19, 1985
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · FRO
3M Company
General & Plastic Surgery · 84d
Cleared Sep 19, 1985
ORALIX PANORAMIC D.C.
K852768 · IZF
Philips Medical Systems, Inc.
Radiology · 83d
Cleared Sep 19, 1985
ALLERCOAT ALLERGEN DISCS
K852794 · DHB
Kallestad Laboratories, Inc.
Immunology · 80d