FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93361–93384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1997
DADE TRU-LIQUID BILIRUBIN CONTROL
K972287 · JJX
Dade Intl., Inc.
Chemistry · 18d
Cleared Jul 03, 1997
NOVIGUARD QUICK DRY
K961044 · LRJ
Dr. Novis Smith & Co., Inc.
General Hospital · 476d
Cleared Jul 03, 1997
2008H ON LINE CLEARANCE MONITOR
K961465 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 442d
Cleared Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
K962767 · HLJ
Alexander Mfg. Co.
Ophthalmic · 352d
Cleared Jul 03, 1997
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS...
K964172 · GZB
Medtronic Vascular
Neurology · 258d
Cleared Jul 03, 1997
SILKAIR LOW AIRLOSS THERAPY
K964873 · IOQ
Hill-Rom, Inc.
Physical Medicine · 210d
Cleared Jul 03, 1997
N-ASSAY TIA MULTI CRP CALIBRATOR SET
K965110 · DCK
Crestat Diagnostics, Inc.
Immunology · 195d
Cleared Jul 03, 1997
INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
K965179 · LLZ
Neo Imagery Technologies, Inc.
Radiology · 191d
Cleared Jul 03, 1997
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · FRN
Abbott Mfg., Inc.
General Hospital · 184d
Cleared Jul 03, 1997
TBD
K965245 · HGI
Utah Medical Products, Inc.
Obstetrics & Gynecology · 184d
Cleared Jul 03, 1997
BIO-ESTHETIC INDIRECT ABUTMENT
K970073 · NHA
Steri-Oss, Inc.
Dental · 176d
Cleared Jul 03, 1997
UNIJECT EXAMINATION GLOVES
K970191 · LYY
Uniject Gloves , Ltd.
General Hospital · 168d
Cleared Jul 03, 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K970300 · LPH
Intermedics Orthopedics
Orthopedic · 160d
Cleared Jul 03, 1997
SHARPS CONTAINER
K970383 · FMI
Custom Medical Plastics, Inc.
General Hospital · 150d
Cleared Jul 03, 1997
SHARPS CONTAINER
K970398 · FMI
Custom Medical Plastics, Inc.
General Hospital · 150d
Cleared Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
K970548 · LDJ
Teco Diagnostics
Toxicology · 141d
Cleared Jul 03, 1997
ONE STEP MORPHINE CARD TEST
K970579 · DNK
Teco Diagnostics
Toxicology · 139d
Cleared Jul 03, 1997
BONE & MARROW CLLECTION SYSTEM
K971268 · GEY
Biomedical International Corp.
General & Plastic Surgery · 87d
Cleared Jul 03, 1997
PURE COMPANY FLUID DELIVERY SYSTEM
K971278 · EIA
Pure Co.
Dental · 87d
Cleared Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Jul 03, 1997
MEDISURF
K971347 · LMD
International Regulatory Consultants
Radiology · 84d
Cleared Jul 03, 1997
MEDRAD FLEX INTERFACE DEVICE
K971380 · LNH
Medrad, Inc.
Radiology · 80d
Cleared Jul 03, 1997
CORDIS OPTA LP PTA BALLOON CATHETER
K971448 · LIT
Cordis Corp.
Cardiovascular · 73d
Cleared Jul 03, 1997
RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
K971489 · IZI
Philips Medical Systems North...
Radiology · 71d