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
89521–89544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 30, 1998
SILICONE PUNCTAL PLUG
K980437 · LZU
Oasis Medical, Inc.
Ophthalmic · 85d
Cleared Apr 30, 1998
SPIROMETER MODEL NPB-500
K980441 · BZG
Nellcor Puritan Bennett, Inc.
Anesthesiology · 85d
Cleared Apr 30, 1998
PEAK FLOW METER MINIMAX
K980443 · BZH
The D&T, Inc.
Anesthesiology · 84d
Cleared Apr 30, 1998
MENTOR SUSPEND SLING
K980483 · FTL
Mentor Corp.
General & Plastic Surgery · 80d
Cleared Apr 30, 1998
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
K980534 · KRH
The Heart Valve Div. Medtronic...
Cardiovascular · 78d
Cleared Apr 30, 1998
JUMBO GLASS IONOMER CEMENT
K980568 · EMA
Centrix, Inc.
Dental · 80d
Cleared Apr 30, 1998
PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
K980616 · EBI
Kohler Medizintechnik GmbH & Co. KG
Dental · 71d
Cleared Apr 30, 1998
N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
K980623 · GCJ
N-Tech Endoscopy, Inc.
General & Plastic Surgery · 72d
Cleared Apr 30, 1998
PROTEC CEM.
K980922 · EMA
Ivoclar North America, Inc.
Dental · 50d