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
78865–78888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · KLS
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 09, 2001
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · ITI
Merits Health Products., Inc.
Physical Medicine · 90d
Cleared May 09, 2001
RUSCH MMG/O'NEIL CATHETER
K010420 · FCM
Rusch, Inc.
Gastroenterology & Urology · 86d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Mitek Products
Orthopedic · 68d
Cleared May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND...
K011065 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 30d
Cleared May 09, 2001
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
K011077 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 30d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120 · DSI
Mennen Medical , Ltd.
Cardiovascular · 396d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · KWQ
Aesculap, Inc.
Orthopedic · 239d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · MQP
Depuyacromed
Orthopedic · 221d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Ortho Tec, LLC
Orthopedic · 90d
Cleared May 08, 2001
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
K010472 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 77d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Bonutti Research, Inc.
Orthopedic · 77d
Cleared May 08, 2001
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
K010542 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 74d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · HWC
Dj Orthopedics, LLC
Orthopedic · 69d
Cleared May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 61d
Cleared May 08, 2001
RANDOX MYOGLOBIN
K010700 · DDR
Randox Laboratories, Ltd.
Chemistry · 61d
Cleared May 08, 2001
MEDLINE STERISET STERILIZATION CONTAINER
K010825 · FRG
Medline
General Hospital · 50d
Cleared May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · GTY
Quidel Corp.
Microbiology · 27d
Cleared May 08, 2001
GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
K011120 · FPA
Nipro Diabetes Systems, Inc.
General Hospital · 26d
Cleared May 08, 2001
AQUARIUS WORKSTATION
K011142 · LLZ
Terarecon,Inc.
Radiology · 25d
Cleared May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · OLV
Nihon Kohden America, Inc.
Neurology · 19d
Cleared May 08, 2001
EXHALE RF PROBE
K011267 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 12d