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
95065–95088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1997
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
K964103 · DWL
Tournier-Bottu S.A.
General Hospital · 87d
Cleared Jan 06, 1997
ARDENT NON GAMMA-2 70
K964192 · EJJ
Ardent Production Development
Dental · 81d
Cleared Jan 06, 1997
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
K964284 · DTK
Boston Scientific Corp
Cardiovascular · 70d
Cleared Jan 03, 1997
RFA-300, LDA UTILITY
K961400 · IYE
Scanditronix Medical AB
Radiology · 267d
Cleared Jan 03, 1997
N95 FILTERING FACEPIECE
K962443 · FXX
Survivair, Inc.
General Hospital · 193d
Cleared Jan 03, 1997
ROLL BELTS
K963467 · FMQ
Deroyal Industries, Inc.
General Hospital · 122d
Cleared Jan 03, 1997
MICRO21 WITH NDNA
K964165 · DHN
Triangle Biomedical Sciences, Inc.
Immunology · 78d
Cleared Jan 03, 1997
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH...
K964326 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 03, 1997
PORTSMART NEEDLE DE-ACCESS ENCLOSURE
K964559 · LJT
Jireh, Inc.
General Hospital · 51d
Cleared Jan 03, 1997
TZ
K964777 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 37d
Cleared Jan 02, 1997
VM PLUS PEAK FLOWMETER
K962074 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 219d
Cleared Jan 02, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM
K962662 · IYO
Diasonics, Inc.
Radiology · 178d
Cleared Jan 02, 1997
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL...
K963255 · JWH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 136d
Cleared Jan 02, 1997
ACURAY DIGITAL X-RAY
K963403 · EHD
New Image Industries, Inc.
Radiology · 126d
Cleared Jan 02, 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K964197 · DSY
Impra, Inc.
Cardiovascular · 73d
Cleared Jan 02, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · ETB
Anthony D. Prescott
Ear, Nose, Throat · 34d
Cleared Jan 02, 1997
SPETEMP EF
K964809 · EMA
Ultradent Products, Inc.
Dental · 34d
Cleared Dec 31, 1996
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
K963184 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 139d
Cleared Dec 31, 1996
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
K963951 · DZE
BioHorizons Implant Systems, Inc.
Dental · 90d
Cleared Dec 31, 1996
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006 · ILO
Hollister, Inc.
Physical Medicine · 85d
Cleared Dec 31, 1996
TIELLE HYDROPOLYMER FOAM DRESSING
K964016 · KMF
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 85d
Cleared Dec 31, 1996
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K964057 · ILO
Hollister, Inc.
Physical Medicine · 83d
Cleared Dec 31, 1996
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K964070 · CAC
Deknatel, Inc.
Anesthesiology · 82d
Cleared Dec 31, 1996
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · GCX
Allegiance Healthcare Corp.
General Hospital · 77d