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
97537–97560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1996
MX703 AND MX730 CONTINUOUS FLUSH DEVICES
K961527 · KRA
Medex, Inc.
Cardiovascular · 45d
Cleared Jun 06, 1996
NON-PRESCRIPTION SUNGLASSES
K961990 · HQY
Rokko Stars Co., Ltd.
Ophthalmic · 16d
Cleared Jun 05, 1996
MEDICOUNT DEKA HEMATOLOGY ANALYZER
K942525 · GKZ
Cea America Corp.
Hematology · 740d
Cleared Jun 05, 1996
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806 · HQX
Mira, Inc.
Ophthalmic · 469d
Cleared Jun 05, 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
K950829 · LSR
Mardx Diagnostics, Inc.
Microbiology · 468d
Cleared Jun 05, 1996
GLOVE SEAL & SET-RITE
K954063 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 281d
Cleared Jun 05, 1996
ACE SREW DENTLA IMPLANT SYSTEM
K954513 · DZE
Ace Surgical Supply Co., Inc.
Dental · 251d
Cleared Jun 05, 1996
ACE CYLINDER DENTAL IMPLANT
K954605 · DZE
Ace Surgical Supply Co., Inc.
Dental · 245d
Cleared Jun 05, 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 205d
Cleared Jun 05, 1996
ACU-LAB
K955776 · LDQ
Glederer & Co., Inc.
General & Plastic Surgery · 168d
Cleared Jun 05, 1996
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
K960045 · KKX
The Sewing Source, Inc.
General Hospital · 155d
Cleared Jun 05, 1996
TINTELIZE PAI-1 KIT
K960438 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 126d
Cleared Jun 05, 1996
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
K960614 · DQA
Somanetics Corp.
Anesthesiology · 113d
Cleared Jun 05, 1996
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
K960676 · DTE
Zoll Medical Corp
Cardiovascular · 106d
Cleared Jun 05, 1996
IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW
K960900 · DZE
Imcor
Dental · 92d
Cleared Jun 05, 1996
SUCTION SAFETY DEVICE
K960937 · MJJ
R D Intl.
Cardiovascular · 89d
Cleared Jun 05, 1996
STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS
K961020 · DZE
Steri-Oss, Inc.
Dental · 85d
Cleared Jun 05, 1996
CNS INTERCHANGEABLE BIT CRANIAL DRILL
K961113 · HBG
Clinical Neuro Systems, LLC
Neurology · 77d
Cleared Jun 05, 1996
TAS A PTT TEST CONTROLS
K961189 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 71d
Cleared Jun 04, 1996
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
K953681 · LKN
Haemonetics Corp.
Gastroenterology & Urology · 302d
Cleared Jun 04, 1996
7100 SWALLOWING WORKSTATION
K954798 · KLA
Kay Elemetrics Corp.
Gastroenterology & Urology · 230d
Cleared Jun 04, 1996
NIPRO ARTERIAL VENOUS FISTULA NEEDLE
K955182 · FIE
Nissho Corp.
Gastroenterology & Urology · 204d
Cleared Jun 04, 1996
SAMS 8000 CARDIOPLEGIA MONITOR
K960916 · DSJ
3M Health Care, Sarns
Cardiovascular · 90d
Cleared Jun 04, 1996
KOWA HAND-HELD APPLANATION TONOMETER HA-1
K960924 · HKY
Kowa Optimed, Inc.
Ophthalmic · 90d