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
146641–146664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1985
INSTRUMENT MAKAR DISPOSALBE LOOP
K853597 · KDC
Instrument Makar, Inc.
General & Plastic Surgery · 27d
Cleared Sep 23, 1985
PERSONAL AMPLIFIER COMMUNICATOR PREMIUM
K853606 · ESD
Electone, Inc.
Ear, Nose, Throat · 26d
Cleared Sep 23, 1985
RIONET HEARING AID HI-06
K853636 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 23, 1985
RIONET HEARING AID HI-07
K853637 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 23, 1985
RIONET HEARING AID
K853638 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 20, 1985
KONTRON FAX FETAL MONITOR
K842422 · HGM
Kontron Instruments, Inc.
Obstetrics & Gynecology · 457d
Cleared Sep 20, 1985
TOMOMATIC 564
K850416 · KPS
M.I.D., Inc.
Radiology · 228d
Cleared Sep 20, 1985
TARGET CAT#B7850AA & B7850AB & B7850B
K851301 · LHN
General Electric Co.
Radiology · 172d
Cleared Sep 20, 1985
THE KENDALL URINARY OUTPUT MONITOR
K852083 · FFO
The Kendal Co.
Gastroenterology & Urology · 130d
Cleared Sep 20, 1985
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · KOD
The Kendal Co.
Gastroenterology & Urology · 130d
Cleared Sep 20, 1985
SAFE-N-JECT
K852304 · FMF
Gerstner Intl. Trade
General Hospital · 114d
Cleared Sep 20, 1985
PHARMA-PLAST NEEDLE
K852442 · FMI
Pharma-Plast USA, Inc.
General Hospital · 102d
Cleared Sep 20, 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · DXK
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Sep 20, 1985
MIC-CONCEPT SYSTEM
K852613 · LTW
Microtech Medical Systems, Inc.
Microbiology · 93d
Cleared Sep 20, 1985
IDECAP DIALYZER
K852764 · FJH
Trans-National Trade Development Corp.
Gastroenterology & Urology · 84d
Cleared Sep 20, 1985
STERILE DISPOSABLE SYRINGE(3 PIECES)
K852819 · FMF
Fabersanitas, S.A.
General Hospital · 81d
Cleared Sep 20, 1985
VIAL DECANTER
K852893 · KPE
Advance Medical Designs, Inc.
General Hospital · 73d
Cleared Sep 20, 1985
PAO VALUE
K852990 · FMF
Ackard Laboratories
General Hospital · 67d
Cleared Sep 20, 1985
N.K. PEDIATRIC CRIBS
K853355 · FMS
N.K. Medical Products, Inc.
General Hospital · 39d
Cleared Sep 20, 1985
SAFTI-BRACELET
K853418 · KMK
Advanced Biosearch Assn.
General Hospital · 37d
Cleared Sep 20, 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 25d
Cleared Sep 19, 1985
KM-2 METAL-BACKED ACETABULAR CUP
K844319 · JDI
Kirschner Medical Corp.
Orthopedic · 317d
Cleared Sep 19, 1985
MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
K850761 · BZN
Medicor USA , Ltd.
Radiology · 206d
Cleared Sep 19, 1985
RT2600(115V)(220/240V) #H4008A & H4008AE
K851807 · IYO
General Electric Co.
Radiology · 142d