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
130945–130968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1989
ARGELITE 54
K893008 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared May 19, 1989
ARGELITE SR+
K893009 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared May 19, 1989
ARGIPAL
K893011 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared May 18, 1989
MODIFIED THER-A-PULSE UNIT
K884396 · IPF
Westec Corp.
Physical Medicine · 211d
Cleared May 18, 1989
SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM
K884732 · DZE
Bio-Interfaces, Inc.
Dental · 189d
Cleared May 18, 1989
SGARLATO LESSER TOE IMPLANT
K884739 · KWH
Sgarlato Laboratories, Inc.
Orthopedic · 185d
Cleared May 18, 1989
MEM-7102
K890274 · GWF
Nihon Kohden America, Inc.
Neurology · 120d
Cleared May 18, 1989
INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)
K891176 · FPA
Multi-Med, Inc.
General Hospital · 73d
Cleared May 18, 1989
DENTIN PRIMER
K891455 · KLE
Dentsply Intl.
Dental · 64d
Cleared May 18, 1989
RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4
K891464 · DYH
Confi-Dental Products Co.
Dental · 64d
Cleared May 18, 1989
SCOPIX LASER IMAGER
K891924 · LMC
Enhanced Imaging Technologies, Inc.
Radiology · 52d
Cleared May 18, 1989
QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
K891931 · JAK
Image Analysis, Inc.
Radiology · 51d
Cleared May 18, 1989
Q5000 PC WORKSTATION
K892113 · DQK
Quinton, Inc.
Cardiovascular · 66d
Cleared May 18, 1989
PULMONARY RESUSCITATOR, MODIFICATION
K892221 · BTM
Life Design Systems, Inc.
Anesthesiology · 49d
Cleared May 18, 1989
ARGEDENT 75
K892234 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared May 18, 1989
DENTAL HAND INSTRUMENTS
K892239 · EKJ
Implant Support Systems, Inc.
Dental · 84d
Cleared May 18, 1989
NEW AM-SERIES DIALYZERS
K892374 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
MODIFIED AM-SERIES DIALYZERS
K892375 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
SUCTION TUBES: HOUSE, BARON
K892549 · GCX
Zinnanti Surgical Instruments, Inc.
General Hospital · 37d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
K892870 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
K892871 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
K892872 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 17, 1989
MCDONALD FOLDING FORCEPS
K885230 · HNR
Alcon Laboratories
Ophthalmic · 148d
Cleared May 17, 1989
LACRIMAL EFFICIENCY TEST (TM)
K890714 · LZU
Lacrimedics, Inc.
Ophthalmic · 93d