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
112249–112272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1993
BOWRON
K922618 · FMZ
G.L. Bowron & Co. , Ltd.
General Hospital · 443d
Cleared Aug 19, 1993
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
K923026 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 422d
Cleared Aug 19, 1993
ARROW BLOOD CONTAINMENT DEVICE
K924558 · DQX
Arrow Intl., Inc.
Cardiovascular · 344d
Cleared Aug 19, 1993
SENSICARE POWDER FREE MEDICAL GLOVE
K925244 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 307d
Cleared Aug 19, 1993
OMNI
K925625 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 286d
Cleared Aug 19, 1993
COMFORTADE
K926435 · FNL
Sensible Products
General Hospital · 239d
Cleared Aug 19, 1993
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · JLW
Sigma Chemical Co.
Chemistry · 226d
Cleared Aug 19, 1993
COBAS CORE PROLACTIN EIA
K930305 · CFT
Roche Diagnostic Systems, Inc.
Chemistry · 210d
Cleared Aug 19, 1993
SURGIC-ALERT MONITOR
K930514 · LDQ
Novatec Medical Products, Inc.--Glove...
General & Plastic Surgery · 199d
Cleared Aug 19, 1993
INFUSION PUMP
K930781 · FRN
Y
General Hospital · 184d
Cleared Aug 19, 1993
MULTILINE
K930793 · GEX
Derma-Lase Co.
General & Plastic Surgery · 184d
Cleared Aug 19, 1993
PROTEIN-BOUND GLUCOSE ASSAYN KIT
K930823 · LCP
Diagnostic Specialties
Hematology · 183d
Cleared Aug 19, 1993
DERMA-LASE DLA-1 LASER
K930975 · GEX
Derma-Lase Co.
General & Plastic Surgery · 176d
Cleared Aug 19, 1993
MI-5 DIAGNOSTIC LIGHT
K931026 · KZF
Medical Illumination, Inc.
General Hospital · 171d
Cleared Aug 19, 1993
Q-11 OPHTHALMIC LASER
K931499 · GEX
Hgm, Inc.
General & Plastic Surgery · 147d
Cleared Aug 19, 1993
ETHYLIDENE AMYL
K931582 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 19, 1993
SILYL AMYL
K931583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 19, 1993
MI-4 VARIABLE SPOT LIGHT
K931646 · KZF
Medical Illumination, Inc.
General Hospital · 139d
Cleared Aug 19, 1993
OLYMPUS REPLY UREA NITROGEN REAGENT
K931745 · CDQ
Olympus Corp.
Chemistry · 136d
Cleared Aug 19, 1993
JARIT ENDOSCOPES, 600-600
K931878 · GCJ
J. Jamner Surgical Instruments, Inc.
General & Plastic Surgery · 127d
Cleared Aug 19, 1993
CALIBRATION GAS
K932520 · BXK
Cryodyne Technologies, Inc.
Anesthesiology · 86d
Cleared Aug 19, 1993
ISI FENESTRATED DISSECTING AND GRASPING FORCEPS
K932534 · GFI
Innovative Surgical, Inc.
General & Plastic Surgery · 83d
Cleared Aug 19, 1993
DC-LINEATE CAT. NO. SE-091
K932555 · JIS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 85d
Cleared Aug 19, 1993
PCI 4000
K932610 · IPF
Pci
Physical Medicine · 83d