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
82945–82968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2000
MODIFICATION TO MARSPO2, MODEL 2001
K000794 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 28d
Cleared Apr 10, 2000
MODIFICATION TO JMS APHERESIS NEEDLE
K000843 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2000
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY...
K000854 · MHX
Agilent Technologies, Inc.
Cardiovascular · 25d
Cleared Apr 10, 2000
REDI-SCREEN
K000979 · LAF
Redwood Biotech, Inc.
Toxicology · 14d
Cleared Apr 10, 2000
MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
K991458 · DXN
Matsushita Electric Corp. of America
Cardiovascular · 350d
Cleared Apr 10, 2000
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272 · FIN
Pure Water, Inc.
Gastroenterology & Urology · 193d
Cleared Apr 10, 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · LIT
Boston Scientific Corp
Cardiovascular · 189d
Cleared Apr 10, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
K993448 · DTB
Ela Medical, Inc.
Cardiovascular · 181d
Cleared Apr 10, 2000
CARDIO-CARD INTERPRETATION SYSTEM I
K993616 · LOS
Nasiff Assoc., Inc.
Cardiovascular · 167d
Cleared Apr 10, 2000
BAYER ADVIA IMS SYSTEM
K993867 · CIG
Bayer Corp.
Chemistry · 147d
Cleared Apr 10, 2000
HMS NEUROMUSCULAR STIMULATOR
K994062 · IPF
Home Medical Services, Inc.
Physical Medicine · 131d
Cleared Apr 10, 2000
5.0MM SPINAL SCREWS
K994288 · MNH
Ortho Tec, LLC
Orthopedic · 112d
Cleared Apr 07, 2000
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
K000061 · EHD
Minxray, Inc.
Radiology · 88d
Cleared Apr 07, 2000
RENEGADE HI-FLO MICROCATHETER
K000177 · KRA
Boston Scientific Corp
Cardiovascular · 78d
Cleared Apr 07, 2000
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
K000261 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, AMPICILLIN, 10MCG
K000268 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, SULFA/TRIMETH
K000271 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, NITROFURANTOIN
K000272 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
K000273 · DJG
Drug Detection Devices, Ltd.
Toxicology · 70d
Cleared Apr 07, 2000
HARDYDISK CEFTRIAXONE 30MCG
K000440 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 07, 2000
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
K000449 · JXM
Drug Detection Devices, Ltd.
Toxicology · 56d
Cleared Apr 07, 2000
HARDYDISK, VANCOMYCIN 30MCG
K000509 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Apr 07, 2000
HARDYDISK, CEFOTAXIME 30MCG
K000524 · JTN
Hardy Diagnostics
Microbiology · 51d