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
97825–97848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1996
CARDIOSMART
K950989 · DPS
Hellige GmbH
Cardiovascular · 437d
Cleared May 13, 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
K951100 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 430d
Cleared May 13, 1996
WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
K953116 · GKZ
Intl. Remote Imaging Systems
Hematology · 315d
Cleared May 13, 1996
ELECTROLYTE STANDARDS
K960592 · JJR
Phoenix Diagnostics, Inc.
Chemistry · 91d
Cleared May 13, 1996
I-SCAN
K960622 · IYO
Ophthalmic Technologies, Inc.
Radiology · 90d
Cleared May 13, 1996
PHEM-CHEK
K960648 · LNW
Femtek, Inc.
Obstetrics & Gynecology · 89d
Cleared May 13, 1996
KANGAROO JEJUNAL FEEDING SYSTEM
K960677 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 87d
Cleared May 13, 1996
EVERGLORY SUNGLASSES
K960735 · HQY
Everglory Creations, Inc.
Ophthalmic · 81d
Cleared May 13, 1996
PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET
K961513 · DYB
Ep Medsystems
Cardiovascular · 24d
Cleared May 13, 1996
TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES
K961523 · HQY
Dorda Toys
Ophthalmic · 21d
Cleared May 13, 1996
SUN CLIP
K961603 · HQY
Intromark, Inc.
Ophthalmic · 18d
Cleared May 10, 1996
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950482 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 462d
Cleared May 10, 1996
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
K954585 · BTR
Rusch Intl.
Anesthesiology · 221d
Cleared May 10, 1996
FLO-STAT FLUID MONITORING SYSTEM
K954775 · HET
Gynecare Innovation Center
Obstetrics & Gynecology · 206d
Cleared May 10, 1996
HEARTPORT ENDOARTERIAL RETURN CANNUAL
K955121 · DWF
Heartport, Inc.
Cardiovascular · 183d
Cleared May 10, 1996
LMI BILIARY CATHETER
K955126 · FGE
Lucas Medical, Inc.
Gastroenterology & Urology · 183d
Cleared May 10, 1996
NEURO-PATCH
K960470 · GXQ
Aesculap, Inc.
Neurology · 99d
Cleared May 10, 1996
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · JMO
Beckman Instruments, Inc.
Chemistry · 98d
Cleared May 10, 1996
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST...
K960593 · CCQ
Aradigm Corp.
Anesthesiology · 88d
Cleared May 10, 1996
SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER
K960820 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 71d
Cleared May 10, 1996
SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD....
K960889 · ELC
San Diego Swiss Machining, Inc.
Dental · 67d
Cleared May 10, 1996
MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
K961120 · HAW
Howmedica Leibinger, Inc.
Neurology · 50d
Cleared May 10, 1996
EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
K961141 · GXY
Uni-Patch, Inc.
Neurology · 50d
Cleared May 10, 1996
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY...
K961262 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 38d