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
125953–125976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1990
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
K900930 · HQX
Oculo Plastik, Inc.
Ophthalmic · 77d
Cleared May 15, 1990
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K900935 · LMD
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 76d
Cleared May 15, 1990
VISUWELL(R) CHLAMYDIA
K900973 · LJC
Adi Diagnostics, Inc.
Microbiology · 74d
Cleared May 15, 1990
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
K900991 · EFS
Tocad America, Inc.
Dental · 74d
Cleared May 15, 1990
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017 · JFJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 71d
Cleared May 15, 1990
SUNGLASSES
K901047 · HQY
Command Marketing Corp.
Ophthalmic · 70d
Cleared May 15, 1990
EDENTEC MODEL 2000W SYSTEM 700 MONITOR
K901060 · DQA
Edentec Corp.
Anesthesiology · 70d
Cleared May 15, 1990
NON-PRESCRIPTION SUNGLASSES
K901168 · HQY
Renauld Intl. , Ltd.
Ophthalmic · 63d
Cleared May 15, 1990
TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE
K901239 · EFB
Teledyne Getz
Dental · 61d
Cleared May 15, 1990
CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES
K901299 · HQY
Sun Mark, Inc.
Ophthalmic · 56d
Cleared May 15, 1990
ASO-CUBE(TM)
K901371 · GTQ
Difco Laboratories, Inc.
Microbiology · 53d
Cleared May 15, 1990
CONCEPT INLAY/ONLAY
K901396 · EBF
Ivoclar North America, Inc.
Dental · 50d
Cleared May 15, 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
K901450 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 48d
Cleared May 15, 1990
LYNX-SM, SCLAER DENTAL HANDPIECE
K901488 · ELC
Mti Precision Products
Dental · 47d
Cleared May 15, 1990
UMBILICAL CORD CLAMP AND CUTTER
K901557 · HFW
Microtek-Heritage, Inc.
Obstetrics & Gynecology · 42d
Cleared May 15, 1990
ESCORT-LINK (MODEL E3200)
K901591 · DXH
Medical Data Electronics
Cardiovascular · 40d
Cleared May 15, 1990
TROBICIN SUSCEPTIBILITY POWDER
K902004 · LOP
The Upjohn Co.
Microbiology · 39d
Cleared May 14, 1990
SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
K894911 · GXZ
Dantec Electronics, Inc.
Neurology · 286d
Cleared May 14, 1990
AP201 DENTAL X-RAY FILM PROCESSOR
K900156 · EGY
Allied Photo Products Co., Inc.
Radiology · 122d
Cleared May 14, 1990
DRESSING CHANGE KIT
K900665 · FXX
Healthdyne Cardiovascular, Inc.
General Hospital · 90d
Cleared May 14, 1990
MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
K900919 · LNH
Summit World Trade Corp.
Radiology · 83d
Cleared May 14, 1990
CHEM I CLINICAL ANALYZER URINE MAGNESIUM
K901124 · JGJ
Technicon Instruments Corp.
Chemistry · 63d
Cleared May 14, 1990
HYCOR ACCUPINCH THC TEST
K901334 · LDJ
Hycor Biomedical, Inc.
Toxicology · 53d
Cleared May 14, 1990
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
K901455 · HSZ
Kirschner Medical Corp.
Orthopedic · 42d