Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
67705–67728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2004
ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH...
K042302 · LDD
Zoll Medical Corp
Cardiovascular · 62d
Cleared Oct 26, 2004
SMK, CX, CXE, RCN
K042375 · GXI
Technomed Europe
Neurology · 55d
Cleared Oct 26, 2004
ACUMEN SHEATH, MODEL TTW7807
K042376 · DYB
Acumen Medical, Inc.
Cardiovascular · 55d
Cleared Oct 26, 2004
COOPER PROSTHETIC
K042435 · LPL
CooperVision, Inc.
Ophthalmic · 48d
Cleared Oct 26, 2004
ENDOREZ
K042756 · KIF
Ultradent Products, Inc.
Dental · 22d
Cleared Oct 26, 2004
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J &...
K042802 · DXN
Health & Life Co., Ltd.
Cardiovascular · 18d
Cleared Oct 25, 2004
GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
K041149 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 175d
Cleared Oct 25, 2004
SCB/VALLEYLAB FORCE FX INTERFACE UNIT
K041912 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 102d
Cleared Oct 25, 2004
AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
K042300 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 25, 2004
SILICONE BLOCK
K042380 · MIB
National Medical Devices, Inc.
General & Plastic Surgery · 54d
Cleared Oct 25, 2004
URO PRO
K042457 · LJH
W.O.M. World of Medicine AG
Gastroenterology & Urology · 45d
Cleared Oct 22, 2004
POLYVAC INSTRUMENT DELIVERY SYSTEM
K040223 · KCT
Symmetry Medical USA, Inc.
General Hospital · 263d
Cleared Oct 22, 2004
MODIFICATION TO SILHOUETTE IC OR SILHOUETTE
K041136 · DZE
Bio-Lok Intl., Inc.
Dental · 175d
Cleared Oct 22, 2004
VASOSTASIS VASCULAR CLOSURE SYSTEM
K041486 · DXC
Cardiva Medical, Inc.
Cardiovascular · 140d
Cleared Oct 22, 2004
GYRUS PLASMACISION LAPAROSCOPIC SPATULA
K041633 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 128d
Cleared Oct 22, 2004
IPLAN!
K041703 · HAW
Brainlab AG
Neurology · 122d
Cleared Oct 22, 2004
CROMAX HIGH SPEED TURBINE HANDPIECE
K041755 · EFB
J.R. Medical Technologies, Inc.
Dental · 115d
Cleared Oct 22, 2004
RM3 RENAL PRESERVATION SYSTEM
K042224 · KDN
Waters Instruments, Inc.
Gastroenterology & Urology · 66d
Cleared Oct 22, 2004
IDI-MRSA ASSAY
K042357 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 52d
Cleared Oct 22, 2004
SMARTMIX PRE-FILLED MIXING SYSTEM
K042591 · KIH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Oct 22, 2004
VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED...
K042604 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 28d
Cleared Oct 22, 2004
UNFORS PATIENT SKIN DOSIMETER (PSD)
K042698 · JAA
Unfors, Inc.
Radiology · 22d
Cleared Oct 22, 2004
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K042728 · GWM
Novus Monitoring, Ltd.
Neurology · 21d
Cleared Oct 22, 2004
QRS-CARD CARDIOLOGY SUITE
K042799 · DQK
Pulse Biomedical, Inc.
Cardiovascular · 14d