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.

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

Filters: Cleared only ×
175,820 results
142417–142440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1986
RESPIRONICS PTL REVIVEEASY
K863172 · CAO
Respironics, Inc.
Anesthesiology · 78d
Cleared Nov 04, 1986
MARTIN MEDICAL PRO-SCOPE ANOSCOPE
K863273 · KOA
Martin Medical
Gastroenterology & Urology · 71d
Cleared Nov 04, 1986
BIO-GUARD AB COATED CATHETER
K863354 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 67d
Cleared Nov 04, 1986
SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES
K863372 · DPT
Interspec, Inc.
Cardiovascular · 63d
Cleared Nov 04, 1986
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · KNN
Cook Urological, Inc.
Physical Medicine · 62d
Cleared Nov 04, 1986
BILIARY BALLOON CATHETER
K863571 · FGE
Uresil Corp.
Gastroenterology & Urology · 53d
Cleared Nov 04, 1986
OSRAM ULTRAMED 400 W
K863937 · FTC
Osram GmbH
General & Plastic Surgery · 26d
Cleared Nov 04, 1986
TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY
K863958 · KOD
Cathaid, Inc.
Gastroenterology & Urology · 25d
Cleared Nov 04, 1986
MODEL XE-103 XENON/MASTER II
K863996 · IYT
Medi Nuclear Corp., Inc.
Radiology · 21d
Cleared Nov 04, 1986
ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T
K864044 · FLL
Respiratory Support Products, Inc.
General Hospital · 19d
Cleared Nov 04, 1986
GENTLE FEEL
K864176 · HFS
Mali, Inc.
General Hospital · 11d
Cleared Nov 03, 1986
WALRUS: DOUBLE BALLOON SHUNTING CATHETER
K862190 · DWF
Medical Parameters, Inc.
Cardiovascular · 147d
Cleared Nov 03, 1986
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
K862260 · LCD
Syva Co.
Toxicology · 143d
Cleared Nov 03, 1986
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
K862436 · BTO
Acutronic Medical Systems AG
Anesthesiology · 130d
Cleared Nov 03, 1986
E-VAC(TM)
K862875 · BTA
Laerdal California, Inc.
General & Plastic Surgery · 96d
Cleared Nov 03, 1986
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
K863353 · ETY
Grason-Stadler, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 03, 1986
SR-IVOLEN TRAY MATERIAL
K863421 · EBH
Ivoclar USA, Inc.
Dental · 60d
Cleared Nov 03, 1986
UPDATED STERILE ENDOTRACHEAL BRUSHES
K863635 · EPE
Biological & Environmental Control...
Anesthesiology · 47d
Cleared Nov 03, 1986
CALIBRATION GAS FOR SERVO GAS MONITOR 120
K863675 · BXK
Siemens Elema AB
Anesthesiology · 45d
Cleared Nov 03, 1986
MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD
K863781 · DTB
Intermedics, Inc.
Cardiovascular · 38d
Cleared Nov 03, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Nov 03, 1986
MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER
K864047 · DTB
Intermedics, Inc.
Cardiovascular · 18d
Cleared Nov 03, 1986
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER
K864048 · DTB
Intermedics, Inc.
Cardiovascular · 17d
Cleared Nov 03, 1986
HITACHI HAND HELD MASSAGER A/C POWERED
K864088 · ISA
Hitachi Sales Corporation of America
Physical Medicine · 13d