FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
114073–114096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1993
ACECUT SUTOMATIC BIOPSY SYSTEM
K930201 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 146d
Cleared Jun 09, 1993
STONE RETRIEVAL BASKET
K930349 · FFL
Endomedix
Gastroenterology & Urology · 135d
Cleared Jun 09, 1993
ACCESS(R) TOTAL IGE ASSAY
K930984 · DGC
Bio-Rad Laboratories, Inc.
Immunology · 104d
Cleared Jun 09, 1993
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM
K931148 · CHQ
Esa, Inc.
Chemistry · 96d
Cleared Jun 09, 1993
VESITEC DRILL GUIDE
K931182 · JDR
Vesitec Medical, Inc.
Orthopedic · 92d
Cleared Jun 09, 1993
SAS PREGNANCY STRIP
K931302 · JHI
Sa Scientific, Inc.
Chemistry · 86d
Cleared Jun 08, 1993
LATEX EXAMINATION GLOVES
K921422 · LYY
Vas Latex Co. , Ltd.
General Hospital · 441d
Cleared Jun 08, 1993
MRH-1500
K922846 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 358d
Cleared Jun 08, 1993
RESTORE TUNNEL PLUG
K923069 · HRX
Depuy, Inc.
Orthopedic · 348d
Cleared Jun 08, 1993
LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME
K923225 · FLK
Lorrex Health Products
General Hospital · 342d
Cleared Jun 08, 1993
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
K924400 · GJT
Behring Diagnostics, Inc.
Hematology · 281d
Cleared Jun 08, 1993
PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM
K924495 · IYE
Philips Medical Systems, Inc.
Radiology · 277d
Cleared Jun 08, 1993
BREAST SIMULATION SYSTEM
K925714 · IYE
Severn Research, Inc.
Radiology · 208d
Cleared Jun 08, 1993
CORT-EX
K926133 · KPS
General Electric Co.
Radiology · 183d
Cleared Jun 08, 1993
SMS BALANCE PERFORMANCE MONITOR
K930089 · KHX
Sms Technologies, Ltd.
Physical Medicine · 151d
Cleared Jun 08, 1993
ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
K930330 · FHQ
Holmed Corp.
Gastroenterology & Urology · 137d
Cleared Jun 08, 1993
HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.
K930352 · GCJ
Ultracision, Inc.
General & Plastic Surgery · 138d
Cleared Jun 08, 1993
MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS
K930355 · GEI
Microsurge, Inc.
General & Plastic Surgery · 134d
Cleared Jun 08, 1993
PENN-PET SCANNER
K930428 · KPS
Ugm Medical Systems, Inc.
Radiology · 133d
Cleared Jun 08, 1993
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
K931002 · IXK
Fujifilm Medical System U.S.A., Inc.
Radiology · 102d
Cleared Jun 08, 1993
DU PONT MV DARKROOM CASSETTE
K931074 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 98d
Cleared Jun 08, 1993
ENDOSCOPIC OR THORASCOPIC FORCEPS
K931259 · GCJ
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 88d
Cleared Jun 08, 1993
MICROVISION FAST DETAIL INTENSIFYING SCREEN
K931283 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 88d
Cleared Jun 08, 1993
PERFECT EAR/PE
K931984 · ESD
Perfect Ear
Ear, Nose, Throat · 47d