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
112489–112512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1993
IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL
K925228 · FPA
Y
General Hospital · 287d
Cleared Jul 30, 1993
TITANIUM COC ABUTMENT HEADS FOR IMZ
K925313 · DZE
Implant Support Systems, Inc.
Dental · 282d
Cleared Jul 30, 1993
PULSE GUARD ELECTRODE
K925396 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 277d
Cleared Jul 30, 1993
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · BSY
Sherwood Medical Co.
Anesthesiology · 269d
Cleared Jul 30, 1993
TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
K925744 · DXQ
Pymah Corp.
Cardiovascular · 259d
Cleared Jul 30, 1993
PRO-2000 LOW AIR LOSS THERAPY BED
K926403 · FNM
Ch Administration, Inc.
General Hospital · 221d
Cleared Jul 30, 1993
MIDMARK SURGICAL LIGHTING SYSTEMS
K930686 · FSQ
Midmark Corp.
General & Plastic Surgery · 170d
Cleared Jul 30, 1993
TRI*STAR
K930711 · FSS
Light Technology Systems
General & Plastic Surgery · 169d
Cleared Jul 30, 1993
REPLACEMENT CAP
K930855 · FPA
Douglas Medical Products Corp.
General Hospital · 162d
Cleared Jul 30, 1993
WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)
K931037 · FWZ
Whitmore Ent., Inc.
General & Plastic Surgery · 151d
Cleared Jul 30, 1993
LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT
K932139 · FSQ
Aaron Medical Industries
General & Plastic Surgery · 87d
Cleared Jul 29, 1993
PERI-K PAD COLD PACK
K920760 · IMD
Baxter Healthcare Corp
Physical Medicine · 526d
Cleared Jul 29, 1993
VIDEO ENDOSCOPE SYSTEM
K922418 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 434d
Cleared Jul 29, 1993
TAMPAX TAMPONS, SUPER ABSORBENCY
K923932 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 358d
Cleared Jul 29, 1993
TAMPAX TAMPON, REGULAR ABSORBENCY
K924303 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 358d
Cleared Jul 29, 1993
GASTROPORT II
K924308 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 337d
Cleared Jul 29, 1993
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · FMF
Sherwood Medical Co.
General Hospital · 328d
Cleared Jul 29, 1993
CARDIAX
K924544 · DPS
Fairlake Marketing Group, Inc.
Cardiovascular · 324d
Cleared Jul 29, 1993
BARD SAFE SAMPLING DEVICE
K925446 · FMI
C.R. Bard, Inc.
General Hospital · 274d
Cleared Jul 29, 1993
PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE
K925631 · HQC
Chiron Intraoptics
Ophthalmic · 262d
Cleared Jul 29, 1993
A.J. MORGAN SUNGLASSES
K925803 · HQY
A.J. Morgan Ent.
Ophthalmic · 255d
Cleared Jul 29, 1993
IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
K925827 · CAC
Impra, Inc.
Anesthesiology · 255d
Cleared Jul 29, 1993
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K925910 · KLK
Hewlett-Packard Co.
Anesthesiology · 248d
Cleared Jul 29, 1993
PROBLOC INSULATED NEEDLES
K926349 · GXZ
Life-Tech Intl., Inc.
Neurology · 224d