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
78985–79008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2001
TRANSAMERICA DIGITAL EMS
K010665 · IPF
Transamerica Medical Systems
Physical Medicine · 52d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · FTL
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared Apr 27, 2001
TRANSAMERICAN TENS
K010782 · GZJ
Transamerica Medical Systems
Neurology · 43d
Cleared Apr 27, 2001
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1,...
K010789 · GCJ
A & A Medical, Inc.
General & Plastic Surgery · 43d
Cleared Apr 27, 2001
SPAZZ
K010823 · IOR
Colours 'N Motion
Physical Medicine · 39d
Cleared Apr 27, 2001
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
K011016 · GCJ
Lsi Solutions
General & Plastic Surgery · 23d
Cleared Apr 27, 2001
SONICAID SYSTEM 8002
K992607 · HGM
Oxford Instruments Medical Systems
Obstetrics & Gynecology · 633d
Cleared Apr 26, 2001
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · DXE
Atrium Medical Corp.
Cardiovascular · 246d
Cleared Apr 26, 2001
EMBOL-X INTRODUCER, MODEL CF00200
K002973 · DYB
Embol-X, Inc.
Cardiovascular · 216d
Cleared Apr 26, 2001
SMARTSCREW MODEL 222006...227510
K003077 · HWC
Bionx Implants, Ltd.
Orthopedic · 205d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 160d
Cleared Apr 26, 2001
URS-1K (KETONE TESST)
K003987 · JIN
Teco Diagnostics
Chemistry · 121d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT...
K004010 · LFR
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Apr 26, 2001
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000...
K004046 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 118d
Cleared Apr 26, 2001
MAGNUM
K010252 · JFB
Magnum Equipment LLC
Physical Medicine · 90d
Cleared Apr 26, 2001
MEDIFACE PACS
K010259 · LLZ
Mediface Co., Ltd.
Radiology · 87d
Cleared Apr 26, 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283 · KXK
Theragenics Corp.
Radiology · 86d
Cleared Apr 26, 2001
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
K010417 · KPT
Nuclear Assoc., Div. Inovision LP
Radiology · 73d
Cleared Apr 26, 2001
FREELITE LAMBDA FREE KIT
K010440 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
FREELITE KAPPA FREE KIT
K010441 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
PICCOLO CHLORIDE TEST SYSTEM
K010670 · CHJ
Abaxis, Inc.
Chemistry · 51d
Cleared Apr 26, 2001
MODIFICATION TO MIRAGE
K010726 · LLZ
Segami Corp., Inc.
Radiology · 45d
Cleared Apr 26, 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 27d
Cleared Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · DIC
Syva Co., Dade Behring, Inc.
Toxicology · 27d