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
94489–94512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1997
MAXCESS NEEDLEFREE - Y- SITE (100713)
K970800 · FPA
Solopak Medical Products, Inc.
General Hospital · 29d
Cleared Apr 02, 1997
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
K970830 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
K970831 · JTN
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
INDOLE SWAB
K970833 · JTO
Remel, Inc.
Microbiology · 26d
Cleared Apr 02, 1997
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K970976 · JJY
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Apr 02, 1997
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
K970979 · JJY
Chiron Diagnostics Corp.
Chemistry · 16d
Cleared Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
K970984 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Apr 01, 1997
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
K952683 · LIH
Wholesale Medical Imports, Inc.
Neurology · 659d
Cleared Apr 01, 1997
CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
K954547 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 550d
Cleared Apr 01, 1997
BENCHMARK TRANSFER TEST
K954730 · BZC
P.K. Morgan , Ltd.
Anesthesiology · 533d
Cleared Apr 01, 1997
ONCE-A-DAY BOWIE AND DICK TEST PACK.
K961156 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 375d
Cleared Apr 01, 1997
UMBILICAL CLAMP AND CUTTER
K963428 · HFW
R.O.S.T. Medical Development, Inc.
Obstetrics & Gynecology · 214d
Cleared Apr 01, 1997
DIOLITE 532
K964074 · GEX
Iriderm Div.
General & Plastic Surgery · 172d
Cleared Apr 01, 1997
LINAC SCALPEL FLOORSTAND
K964517 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 140d
Cleared Apr 01, 1997
FPT NEBULIZER
K970010 · CAF
Fluid Propulsion Technologies, Inc.
Anesthesiology · 89d
Cleared Apr 01, 1997
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER,...
K970035 · CAF
Graham-Field, Inc.
Anesthesiology · 88d
Cleared Apr 01, 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290 · KTT
Ebi, L.P.
Orthopedic · 67d
Cleared Apr 01, 1997
NEO-PICC
K970434 · LJS
Klein-Baker Medical, Inc.
General Hospital · 55d
Cleared Apr 01, 1997
UPSCAN 120
K970450 · LLZ
Merlin Engineering Works, Inc.
Radiology · 54d
Cleared Apr 01, 1997
D SERIES ELECTRODE
K970603 · DSB
Cmc Sense-It, Inc.
Cardiovascular · 42d
Cleared Apr 01, 1997
REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE
K970924 · KGO
Regent Medical
General Hospital · 25d
Cleared Apr 01, 1997
PROSTYLE INTRA
K970975 · EHD
Planmeca Oy
Radiology · 15d
Cleared Mar 31, 1997
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
K962370 · EJR
Challenge Products, Inc.
Dental · 285d
Cleared Mar 31, 1997
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT
K963843 · EFB
Micro Motors, Inc.
Dental · 187d