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
159817–159840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1982
REMOVAWELL TISSUE CULTURE PLATE W/LID
K821687 · KIZ
Dynatech Corp.
Microbiology · 16d
Cleared Jun 24, 1982
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K821699 · FOZ
Warner-Lambert Co.
General Hospital · 16d
Cleared Jun 24, 1982
FRACTURE BRACING
K821704 · IQI
Hosmer Dorrance Corp.
Physical Medicine · 22d
Cleared Jun 24, 1982
AMMONIA REAGENT
K821719 · JIF
Gilford Diagnostics
Microbiology · 14d
Cleared Jun 24, 1982
T3 UPTAKE DIAGNOSTIC KIT
K821722 · KHQ
Diagnostic Reagents, Inc.
Chemistry · 14d
Cleared Jun 24, 1982
T3 DIAGNOSTIC KIT RIA
K821725 · CDP
Diagnostic Reagents, Inc.
Chemistry · 16d
Cleared Jun 24, 1982
BARDEX ALL SILICONE PEDIATRIC CATHETER
K821745 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared Jun 24, 1982
A O FIBER OPTIC ILLUMINATION, 1185A
K821753 · FCR
Warner-Lambert Co.
Gastroenterology & Urology · 9d
Cleared Jun 24, 1982
A O FIBER OPTIC ILLUMINATOR, 1185B
K821754 · FCR
Warner-Lambert Co.
Gastroenterology & Urology · 9d
Cleared Jun 24, 1982
EMIT - ST URINE METHAGUALONE CONTROLS
K821766 · LAS
Syva Co.
Toxicology · 9d
Cleared Jun 24, 1982
EMIT ST URINE METHAGUALONE ASSAY
K821768 · KXS
Syva Co.
Chemistry · 9d
Cleared Jun 24, 1982
EZ-FIX I.V. CATHETER HOLDER
K821796 · KMK
Dyna Care
General Hospital · 6d
Cleared Jun 23, 1982
HEMODIALYSIS SYSTEM
K813432 · FKP
Fhk
Gastroenterology & Urology · 197d
Cleared Jun 23, 1982
HOLLOW FIBER DIALYZERS
K820743 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 96d
Cleared Jun 23, 1982
URETHANE ORTHOPAEDIC CASTING TAPE
K820890 · ITG
Hexcel Medical
Physical Medicine · 85d
Cleared Jun 23, 1982
MEDTRONIC #1992-2 DUAL RATE TRANSMITTER
K820988 · GZB
Medtronic Vascular
Neurology · 77d
Cleared Jun 23, 1982
PATIENT PREP KITS/TRAYS-STERILE
K821044 · FRG
Phoenix Glove Co.
General Hospital · 70d
Cleared Jun 23, 1982
HETERODYNAMIC
K821157 · IPF
Birtcher Corp.
Physical Medicine · 62d
Cleared Jun 23, 1982
COUNTER-ROTATION SYSTEM
K821256 · ITN
The Langer Group
Physical Medicine · 54d
Cleared Jun 23, 1982
VITASAN
K821259 · FQL
Selomas, Inc.
General Hospital · 54d
Cleared Jun 23, 1982
VITOFIT
K821260 · FQL
Selomas, Inc.
General Hospital · 54d
Cleared Jun 23, 1982
TRANSDUCER FILTER
K821268 · FIB
Cp Medical
Gastroenterology & Urology · 51d
Cleared Jun 23, 1982
ECHO, MODEL MM-1000
K821383 · LIF
Mesa Medical, Inc.
Gastroenterology & Urology · 44d
Cleared Jun 23, 1982
MAHURKAR SUBCLAVIAN CATHETER
K821400 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 43d