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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157273–157296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1983
C.A.T. REAGENT KIT
K830322 · JTQ
Remel Co.
Microbiology · 56d
Cleared Mar 25, 1983
CORSTREN COMPRESSION TUBE & PLATE
K830196 · KTT
Zimmer, Inc.
Orthopedic · 64d
Cleared Mar 25, 1983
PHADEZYM B2 MICRO TEST 100
K830280
Pharmacia, Inc.
Immunology · 58d
Cleared Mar 25, 1983
PDB II
K830289 · INQ
J.A. Gerber Therapeutical, Ltd.
Physical Medicine · 57d
Cleared Mar 25, 1983
CORNING 102 PRINTER
K830296 · JQP
Corning Medical & Scientific
Chemistry · 57d
Cleared Mar 24, 1983
AMBULATORY MARK I
K822842 · FRN
Windsor Medical, Inc.
General Hospital · 182d
Cleared Mar 24, 1983
DEVETHERM
K822873 · DQB
Eko Scann AB
Cardiovascular · 178d
Cleared Mar 24, 1983
PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630
K823334 · DRS
Psitron
Cardiovascular · 136d
Cleared Mar 24, 1983
ELPHA 500
K823581 · GCJ
Prothia USA, Inc.
General & Plastic Surgery · 108d
Cleared Mar 24, 1983
PHADEBAS & PHADEZYM RAST TEST ALLERG
K823592 · DHB
Pharmacia, Inc.
Immunology · 108d
Cleared Mar 24, 1983
SAHOTA-KAPLAN HEMOSTAT
K823754 · DQO
Erickson Industries, Inc.
Cardiovascular · 100d
Cleared Mar 24, 1983
SCANLAN SINGLE-USE AORTA PUNCH
K823764 · DWS
Scanlan Intl., Inc.
Cardiovascular · 100d
Cleared Mar 24, 1983
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878 · DXY
Pacesetter Systems
Cardiovascular · 87d
Cleared Mar 24, 1983
SURGICAL BLADES
K823905 · GEI
Designs IN Medicine
General & Plastic Surgery · 86d
Cleared Mar 24, 1983
SEPTOCAL
K830111
North Pacific Dental, Inc.
Dental · 72d
Cleared Mar 24, 1983
CARDIOVASCULAR SAW BLADES
K830189 · DWH
Temp Medical Products, Inc.
General & Plastic Surgery · 64d
Cleared Mar 24, 1983
API TB-IDENT*
K830211 · JSY
Analytical Products, Inc.
Microbiology · 59d
Cleared Mar 24, 1983
RIONET HEARING AID
K830236 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 24, 1983
FLORET NASAL TAMPON
K830263 · LYA
Ritmed, Inc.
General & Plastic Surgery · 58d
Cleared Mar 24, 1983
MEDILOG 9000 SYSTEM
K830295 · GWQ
Oxford Medilog, Inc.
Neurology · 56d
Cleared Mar 24, 1983
UNIFLEX
K830316 · BXB
Buckman Consultants
Physical Medicine · 52d
Cleared Mar 24, 1983
DOSIMETRIC RELEASE OF RADIATION DEV
K830327 · DTZ
American Bentley
Cardiovascular · 51d
Cleared Mar 24, 1983
BACTEC 170 TRYPTIC SOY BROTH W/RESINS
K830363 · LJF
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Mar 24, 1983
STERILE, DISPOSABLE, HYPODERMIC NEEDLES
K830378 · GAA
Abco Dealers, Inc.
General & Plastic Surgery · 48d