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
134545–134568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1988
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · JEC
Kirschner Medical Corp.
Orthopedic · 84d
Cleared Jul 28, 1988
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
K881968 · DSB
Biodynamics Corp.
Cardiovascular · 78d
Cleared Jul 28, 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · DXO
Draeger Medical, Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER
K882034 · DWF
Buckman Co., Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
HEART-CHILL SALINE SLUSH PAD
K882035 · DWJ
Buckman Co., Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
PROPAQ 104(TM)
K882085 · DSK
Protocol Systems, Inc.
Cardiovascular · 71d
Cleared Jul 28, 1988
QTEST(TM) PREGNANCY
K882086 · JHI
Quidel Corp.
Chemistry · 71d
Cleared Jul 28, 1988
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 70d
Cleared Jul 28, 1988
TUNNELING STYLET
K882097 · DRB
Quinton, Inc.
Cardiovascular · 70d
Cleared Jul 28, 1988
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
K882188 · DXN
Ivy Biomedical Systems, Inc.
Cardiovascular · 65d
Cleared Jul 28, 1988
MINIMON 7132B PATIENT MONITOR
K882198 · DPS
Kontron Instruments, Inc.
Cardiovascular · 64d
Cleared Jul 28, 1988
CLEARBLUE EASY
K882416 · LCX
Unipath , Ltd.
Chemistry · 45d
Cleared Jul 28, 1988
GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
K882450 · JJE
Diamond Sensor Systems
Chemistry · 44d
Cleared Jul 28, 1988
BREVET CASSETTE STERILIZATION MODULE
K882617 · FSM
Brevet, Inc.
General & Plastic Surgery · 34d
Cleared Jul 28, 1988
SIGMA 1 WOBBLER BIOPSY KIT
K882673 · FCH
Kontron Instruments, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 28, 1988
SLIP-COAT(TM) CATHETERS
K882796 · DQO
Cook, Inc.
Cardiovascular · 22d
Cleared Jul 28, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2180
K882838 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
EARLE'S BALANCED SALTS (EBSS) NO. 200-2506
K882839 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
HANK'S BALANCED SALTS (HBSS) NO. 200-2520
K882840 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
HANK'S BALANCED SALTS (HBSS) NO. 200-2521
K882841 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
EARLE'S BALANCED SALTS (EBSS) NO. 200-2505
K882842 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
HANK'S BALANCED SALTS NO. 200-2515
K882843 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
HANK'S BALANCED SALTS NO. 200-2510
K882844 · KIT
J R Scientific
Pathology · 20d
Cleared Jul 28, 1988
EARLE'S BALANCED SALTS NO. 200-2500
K882845 · KIT
J R Scientific
Pathology · 20d