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
82657–82680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
K000087 · FOZ
The Kendal Co.
General Hospital · 65d
Cleared Mar 17, 2000
BUILD-IT FR
K000211 · EBF
Jeneric/Pentron, Inc.
Dental · 53d
Cleared Mar 17, 2000
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
K000286 · JZO
Brahms Diagnostica, LLC
Immunology · 46d
Cleared Mar 17, 2000
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
K000287 · JZO
Brahms Diagnostica, LLC
Immunology · 46d
Cleared Mar 17, 2000
VARELISA SM ANTIBODIES
K000312 · LKP
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared Mar 17, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K000359 · JAK
Imatron, Inc.
Radiology · 42d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · KKX
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Mar 17, 2000
ELECTROSURGICAL GENERATOR, MODEL S1
K000501 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 31d
Cleared Mar 17, 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550 · FGE
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 17, 2000
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000583 · CGA
Selfcare, Inc.
Chemistry · 24d
Cleared Mar 17, 2000
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
K000644 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 21d
Cleared Mar 17, 2000
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
K992481 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 235d
Cleared Mar 17, 2000
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K992513 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 235d
Cleared Mar 17, 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · MEG
Safeguard Medical Products, Inc.
General Hospital · 144d
Cleared Mar 17, 2000
SYNOCTA ANGLED ABUTMENTS
K994119 · DZE
Straumann USA
Dental · 102d
Cleared Mar 17, 2000
LOCATOR IMPLANT ANCHOR
K994257 · DZE
Zest Anchors, Inc.
Dental · 92d
Cleared Mar 17, 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K994280 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Mar 17, 2000
SOLO ORTHO 2
K994309 · DYH
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Mar 17, 2000
UMBILICAL CORD CLAMP
K994367 · HFW
Medical Sales Co.
Obstetrics & Gynecology · 81d
Cleared Mar 16, 2000
IMAGE X-70 PLUS DENTAL X-RAY UNIT
K000551 · EHD
Medical Device Consultants, Inc.
Radiology · 27d
Cleared Mar 16, 2000
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING...
K000695 · IYO
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Mar 16, 2000
MEMOTHERM COLORECTAL STENT
K990504 · MQR
C.R. Bard, Inc.
Gastroenterology & Urology · 393d
Cleared Mar 16, 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881 · KXK
Sourcetech Medical, LLC
Radiology · 288d
Cleared Mar 16, 2000
MSP M/K BLADE
K993122 · HNO
Medical Sterile Products, Inc.
Ophthalmic · 178d