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
90025–90048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1998
CREATINE KINASE (CK)
K981218 · CGS
Abbott Laboratories
Chemistry · 28d
Cleared May 01, 1998
IRON
K981241 · JIY
Abbott Laboratories
Chemistry · 25d
Cleared May 01, 1998
IRMA BLOOD ANALYSIS SYSTEM
K981270 · CGZ
Diametrics Medical, Inc.
Chemistry · 24d
Cleared May 01, 1998
N-ASSAY L D-BIL
K981276 · CIG
Crestat Diagnostics, Inc.
Chemistry · 23d
Cleared May 01, 1998
ELECSYS AFP
K981282 · LOJ
Roche Diagnostics GmbH
Immunology · 23d
Cleared May 01, 1998
TBIL
K981336 · CIG
Abbott Laboratories
Chemistry · 18d
Cleared May 01, 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354 · LOJ
Beckman Instruments, Inc.
Immunology · 17d
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER...
K981368 · FOZ
Catheter Innovations, Inc.
General Hospital · 16d
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER...
K981382 · FOZ
Catheter Innovations, Inc.
General Hospital · 15d
Cleared Apr 30, 1998
E100 SERIES SPO2 SENSORS
K970098 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 472d
Cleared Apr 30, 1998
MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
K970139 · DPW
Micro Weiss Electronics
Cardiovascular · 470d
Cleared Apr 30, 1998
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
K970211 · DPW
Micro Weiss Electronics
Cardiovascular · 464d
Cleared Apr 30, 1998
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K970460 · CBK
Puritan Bennett Corp.
Anesthesiology · 448d
Cleared Apr 30, 1998
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
K971377 · CCW
Wilson Greatbatch Technologies, Inc.
Anesthesiology · 381d
Cleared Apr 30, 1998
TOENNIES NEUROSCREEN SYSTEM
K972419 · IKN
Erich Jaeger, Inc.
Neurology · 307d
Cleared Apr 30, 1998
RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
K972705 · FMI
Sage Products, Inc.
General Hospital · 283d
Cleared Apr 30, 1998
SIS WOUND DRESSING
K973170 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 248d
Cleared Apr 30, 1998
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
K973335 · JQW
Zenyx Scientific , Ltd.
Chemistry · 238d
Cleared Apr 30, 1998
BAIR HUGGER BLOOD/FLUID WARMER
K973741 · BSB
Augustine Medical, Inc.
Hematology · 211d
Cleared Apr 30, 1998
CS2000 & CS2000 TOMO
K973834 · IZF
Pausch Corp.
Radiology · 204d
Cleared Apr 30, 1998
MEDRAD ATD-T INTERFACE DEVICE
K974438 · MOS
Medrad, Inc.
Radiology · 157d
Cleared Apr 30, 1998
MOOORLDI LASER DOPPLER IMAGER
K980383 · DPT
Moor Instruments, Ltd.
Cardiovascular · 87d
Cleared Apr 30, 1998
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
K980399 · HQE
Peregrine Surgical , Ltd.
Ophthalmic · 87d
Cleared Apr 30, 1998
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
K980400 · HQE
Peregrine Surgical , Ltd.
Ophthalmic · 87d