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
89281–89304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1998
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
K973840 · DYB
Daig Corp.
Cardiovascular · 225d
Cleared May 21, 1998
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
K973929 · IPF
Neotonus, Inc.
Physical Medicine · 218d
Cleared May 21, 1998
PLUS REUSABLE RESUSCITATOR
K974141 · BTM
Schiff & Co.
Anesthesiology · 199d
Cleared May 21, 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571 · FPA
Baxter Healthcare Corp
General Hospital · 164d
Cleared May 21, 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA...
K974695 · CKB
Roche Diagnostic Systems, Inc.
Chemistry · 156d
Cleared May 21, 1998
FLEXIBLE FIBERSCOPES AND ACCESSORIES
K980401 · FAJ
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 108d
Cleared May 21, 1998
SPYROSORB FOAM ISLAND WOUND DRESSING
K980673 · KMF
Innovative Technologies (Us), Inc.
General & Plastic Surgery · 90d
Cleared May 21, 1998
SPIGAL NEEDLE
K980676 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 90d
Cleared May 21, 1998
NEOCOLLOID, ORTHOPRINT
K981091 · ELW
Zhermack S.P.A.
Dental · 57d
Cleared May 20, 1998
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K972595 · BSP
Avid N.I.T., Inc.
Anesthesiology · 313d
Cleared May 20, 1998
SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX...
K973615 · LYY
Macro Rubber Industrial, Inc.
General Hospital · 239d
Cleared May 20, 1998
PINPOINT
K974513 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 170d
Cleared May 20, 1998
PHOTODERM HR SYSTEM
K974536 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 169d
Cleared May 20, 1998
SIS HERNIA REPAIR DEVICE
K974540 · FTL
Sentron Medical, Inc.
General & Plastic Surgery · 168d
Cleared May 20, 1998
ULTRA BILI LIGHT
K974830 · LBI
Physician Engineered Products, Inc.
General Hospital · 147d
Cleared May 20, 1998
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
K980125 · KGI
Norland Corp.
Radiology · 126d
Cleared May 20, 1998
DUREX ULTRA COMFORT
K980319 · HIS
London Intl., LLC
Obstetrics & Gynecology · 113d
Cleared May 20, 1998
SKAR-KARE SHEET
K980563 · MDA
Life Medical Sciences, Inc.
General & Plastic Surgery · 96d
Cleared May 20, 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K980636 · FFS
Dutch Ophthalmic USA, Inc.
Gastroenterology & Urology · 90d
Cleared May 20, 1998
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665 · HRY
Biomet, Inc.
Orthopedic · 89d
Cleared May 20, 1998
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
K980685 · GEX
Lumenis, Inc.
General & Plastic Surgery · 86d
Cleared May 20, 1998
RADIOCAMERAS PATIENT POSITIONING SYSTEM
K980750 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 83d
Cleared May 20, 1998
DUAL LOCK HIP STEM
K980794 · JDI
Depuy, Inc.
Orthopedic · 79d
Cleared May 20, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
K980837 · JAK
Shimadzu Medical Systems
Radiology · 77d