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
169681–169704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1979
MODEL 1051, MONITOR
K790328 · DXN
Applied Medical Research
Cardiovascular · 14d
Cleared Mar 02, 1979
GRAB-IT
K790367 · GEI
Concept, Inc.
General & Plastic Surgery · 8d
Cleared Mar 01, 1979
THE BLUE MASK
K782163 · BSJ
Collectovac, Inc.
Anesthesiology · 70d
Cleared Feb 28, 1979
RIA KIT, VITAMIN B12
K782024 · CDD
Technia Diagnostics , Ltd.
Chemistry · 85d
Cleared Feb 28, 1979
MONITOR SCOPES, MODELS 9502, 9503
K790004 · DRT
C-V Monitors Corp.
Cardiovascular · 57d
Cleared Feb 28, 1979
ANALYZER, MEDILOG II
K790287 · DSI
Oxford Medilog, Inc.
Cardiovascular · 20d
Cleared Feb 27, 1979
HEMO-NATE SYRINGE BLOOD FILTER
K781815 · FPB
Gisco Intl.
General Hospital · 126d
Cleared Feb 27, 1979
INFUSION PUMP, MODEL AS*5
K782034 · FRN
Baxter Healthcare Corp
General Hospital · 83d
Cleared Feb 27, 1979
CATHETER, RADIOPAQUE TENCKHOFF
K782057 · FJS
Dravon Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 27, 1979
CATHETER, BETA-CAP-PERITONEAL
K782058 · FJS
Dravon Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 27, 1979
ODONTOSON 3
K782133 · ELC
Mdt Corp., Inc.
Dental · 62d
Cleared Feb 27, 1979
GDC-591
K790006 · EJT
Deringer-Ney, Inc.
Dental · 56d
Cleared Feb 27, 1979
BED, PARAPLEGIC
K790049 · FNL
Wayne V. Kirkman
General Hospital · 49d
Cleared Feb 27, 1979
BAR & RIDER, SCREWS, TUBES
K790078 · ECG
Eurodent, Inc.
Dental · 48d
Cleared Feb 27, 1979
SKIN CLOSURE TAPES STERILE
K790140 · FPX
Shur Medical Corp.
General & Plastic Surgery · 39d
Cleared Feb 27, 1979
BK-5098 TILT TABLE STRAP
K790172 · FMQ
Fred Sammons, Inc.
General Hospital · 32d
Cleared Feb 27, 1979
BOVIE HAND CONTROL
K790187 · GEI
Sybron Corp.
General & Plastic Surgery · 29d
Cleared Feb 27, 1979
STOCKINETTE, TUBULAR UNBLEACHED
K790210 · FQM
The Owenby Co.
General Hospital · 28d
Cleared Feb 27, 1979
MEDTRONIC TEMPTRON
K790261 · DTB
Medtronic Vascular
Cardiovascular · 21d
Cleared Feb 27, 1979
HEARING AID MODEL 8143
K790270 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 27, 1979
RECORDER, MEDILOG II
K790286 · DSH
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
STORAGE, DIGITAL DSC-1, CONTROL UNIT
K790288 · DXG
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
PB-4 REPLAY UNIT
K790289 · DSH
Oxford Medilog, Inc.
Cardiovascular · 19d
Cleared Feb 27, 1979
PREAMPLIFIER MODULE, EKG RESPIRATION
K790304 · BZQ
Abbott Medical Electronics Co.
Anesthesiology · 14d