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
82441–82464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 07, 2000
HARDYDISK OFLOXACIN 5MCG
K000525 · JTN
Hardy Diagnostics
Microbiology · 51d
Cleared Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 30d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 24d
Cleared Apr 07, 2000
MDI SCL-70 TEST
K000934 · LJM
Micro Detect, Inc.
Immunology · 15d
Cleared Apr 07, 2000
KFA-63 KNEE AND FOOT ARRAY
K000935 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 284d
Cleared Apr 07, 2000
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
K993414 · DPS
Prucka Engineering, Inc.
Cardiovascular · 178d