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
82105–82128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · BZD
Respironics, Inc.
Anesthesiology · 190d
Cleared Sep 08, 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 94d
Cleared Sep 08, 2000
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
K001766 · FDS
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Sep 08, 2000
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP,...
K001951 · FXX
Primeline Medical Products, Inc.
General Hospital · 73d
Cleared Sep 08, 2000
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
K001995 · DQA
Qrs Diagnostic, LLC
Anesthesiology · 70d
Cleared Sep 08, 2000
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 59d
Cleared Sep 08, 2000
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN...
K002111 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 58d
Cleared Sep 08, 2000
SUPER 3
K002299 · EJH
Dental Alloy Products, Inc.
Dental · 42d
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