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
81505–81528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2000
SUPER 12
K002301 · EJH
Dental Alloy Products, Inc.
Dental · 42d
Cleared Sep 08, 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · BZD
Respironics, Inc.
Anesthesiology · 28d
Cleared Sep 08, 2000
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A...
K002470 · IYN
Agilent Technologies, Inc.
Radiology · 28d
Cleared Sep 08, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002477 · DQA
Masimo Corp.
Anesthesiology · 28d
Cleared Sep 08, 2000
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN...
K002579 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 21d
Cleared Sep 07, 2000
INPLANT ORTHODONTIC ANCHOR SYSTEM
K000643 · DZE
Nobel Biocare Uas, Inc.
Dental · 195d
Cleared Sep 07, 2000
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
K000830 · DWF
California Medical Laboratories, Inc.
Cardiovascular · 177d
Cleared Sep 07, 2000
ZORTRAN DETECTOR
K000997 · FOZ
Lucent Medical Systems
General Hospital · 163d
Cleared Sep 07, 2000
P.O.P. PAIN KIT
K001342 · MEB
Post Operative Pain Management
General Hospital · 133d
Cleared Sep 07, 2000
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · KXK
Surgical Specialties Corp
Radiology · 87d
Cleared Sep 07, 2000
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
K001872 · FPA
Codan US Corp.
General Hospital · 79d
Cleared Sep 07, 2000
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM,...
K002060 · HIS
Dongkuk Techco Rubber Industries
Obstetrics & Gynecology · 63d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 183d
Cleared Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT...
K001149 · DWJ
Augustine Medical, Inc.
Cardiovascular · 149d
Cleared Sep 06, 2000
GYROSCAN INTERA (R7.5)
K001796 · LNH
Philips Medical Systems North...
Radiology · 84d
Cleared Sep 06, 2000
EXPLORER GRADIENT
K001987 · LNH
Philips Medical Systems North...
Radiology · 69d
Cleared Sep 06, 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · BZD
Puritan Bennett Corp.
Anesthesiology · 68d
Cleared Sep 06, 2000
PHILIPS INTEGRIS ALLURA
K002016 · OWB
Philips Medical Systems North...
Radiology · 65d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026 · DTM
Terumo Medical Corp.
Cardiovascular · 65d
Cleared Sep 06, 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 51d
Cleared Sep 06, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002574 · DQA
Masimo Corp.
Anesthesiology · 19d
Cleared Sep 06, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
K002655 · DXN
Meditec Co., Ltd.
Cardiovascular · 12d
Cleared Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · JPA
Roche Diagnostics Corp.
Hematology · 258d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · CGA
Roche Diagnostics Corp.
Chemistry · 75d