FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126625–126648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1990
MIRROR SHIELD
K901053 · EKJ
Pulpdent Corp.
Dental · 63d
Cleared May 07, 1990
MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
K901087 · JDI
Depuy, Inc.
Orthopedic · 59d
Cleared May 07, 1990
MULTI-STRIP
K901228 · FKX
Bellhouse Medical, Inc.
Gastroenterology & Urology · 54d
Cleared May 07, 1990
DIGIFORMER HR DFP-50A
K901405 · JAA
Toshiba America Medical Systems, In.C
Radiology · 42d
Cleared May 07, 1990
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
K901602 · LNH
Resonex, Inc.
Radiology · 31d
Cleared May 07, 1990
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
K901620 · LNH
Instrumentarium Imaging, Inc.
Radiology · 32d
Cleared May 07, 1990
INAMED SMALL DRAIN SYSTEM
K901742 · GCY
Inamed Development Co.
General & Plastic Surgery · 20d
Cleared May 07, 1990
STERILE SUCTION TUBING SET
K901761 · BYY
Acacia Laboratories, Inc.
General Hospital · 19d
Cleared May 07, 1990
INAMED CONVERTIBLE DRAIN SYSTEM
K901764 · GCY
Inamed Development Co.
General & Plastic Surgery · 19d
Cleared May 07, 1990
AIR CUSHIONED AUTO WHEELCHAIR LIFT ACL-200/AG-Z2
K901794 · ING
Metal Dynamics Corp.
Physical Medicine · 18d
Cleared May 07, 1990
MARK IV FLOATATION THERAPY BED
K901890 · IOQ
Hydrothermic Floatation Systems, Inc.
Physical Medicine · 11d
Cleared May 04, 1990
NUFFIELD TOTAL KNEE
K892503 · JWH
Orthopedic Systems, Inc.
Orthopedic · 388d
Cleared May 04, 1990
CONDOM (RUBBER) CONTRACEPTIVE
K893039 · HIS
Chinteik Hygiene Products Co., Ltd.
Obstetrics & Gynecology · 375d
Cleared May 04, 1990
FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
K896288 · FFT
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 186d
Cleared May 04, 1990
MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG
K900630 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 85d
Cleared May 04, 1990
MICROTEK MEDICAL'S BLOOD COLLECTION KIT
K900726 · JKA
Microbio-Medics, Inc.
Chemistry · 78d
Cleared May 04, 1990
B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE
K900767 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 77d
Cleared May 04, 1990
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
K900774 · LKY
Dacomed Corp.
Gastroenterology & Urology · 73d
Cleared May 04, 1990
MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
K900832 · JDI
Depuy, Inc.
Orthopedic · 71d
Cleared May 04, 1990
BIOSIGN HCG-ONE STEP PREGNANCY TEST
K901011 · JHI
Princeton Biomedix
Chemistry · 60d
Cleared May 04, 1990
VACUUM ERECTION DEVICE (VED)
K901223 · LKY
Mission Pharmacal Co.
Gastroenterology & Urology · 51d
Cleared May 04, 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
K901229 · CGX
Technicon Instruments Corp.
Chemistry · 51d
Cleared May 04, 1990
STAYEREC SYSTEM(TM)
K901318 · LKY
Osbon Medical Systems, Ltd.
Gastroenterology & Urology · 44d
Cleared May 04, 1990
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · KOB
Bivona Medical Technologies
Gastroenterology & Urology · 38d