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
133609–133632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · JJQ
Pharmacia, Inc.
Toxicology · 59d
Cleared Oct 13, 1988
INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
K883439 · DTR
Medtronic Blood Systems, Inc.
Cardiovascular · 59d
Cleared Oct 13, 1988
STERI-TAG(TM) STERILE LABEL SETS
K883654 · LYV
Acacia Laboratories, Inc.
General & Plastic Surgery · 48d
Cleared Oct 13, 1988
HLE-1000 HIGH/LOW TREATMENT TABLE
K883659 · INQ
Rich-Mar Corp.
Physical Medicine · 48d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737 · LNH
Resonex, Inc.
Radiology · 42d
Cleared Oct 13, 1988
STERILE SURGICAL LATEX GLOVES
K883824 · KGO
Intl. Trading Ventures, Inc.
General Hospital · 34d
Cleared Oct 13, 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861 · JJY
Casco Standards
Chemistry · 30d
Cleared Oct 13, 1988
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · LWJ
Osteonics Corp.
Orthopedic · 27d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Oct 13, 1988
VISION CREATINE KINASE
K883946 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Oct 13, 1988
ALM OPERATING TABLES
K884019 · FWX
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 21d
Cleared Oct 13, 1988
MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K884032 · GZJ
Morgan Associates, Inc.
Neurology · 20d
Cleared Oct 13, 1988
MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940
K884039 · FWH
Medical Dynamics, Inc.
General & Plastic Surgery · 17d
Cleared Oct 13, 1988
SURGI-TAG(TM) STERILE LABEL SETS
K884055 · LYV
Acacia Laboratories, Inc.
General & Plastic Surgery · 17d
Cleared Oct 13, 1988
LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)
K884073 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 16d
Cleared Oct 13, 1988
SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80
K884092 · GEX
Surgilase, Inc.
General & Plastic Surgery · 15d
Cleared Oct 13, 1988
LTDT PATIENT LIFTER
K884110 · ILK
Devine Medical Products
Physical Medicine · 14d
Cleared Oct 13, 1988
CARETEX OR TOWEL
K884112 · KKX
James River Corp.
General Hospital · 14d
Cleared Oct 12, 1988
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · JWH
Howmedica Corp.
Orthopedic · 314d
Cleared Oct 12, 1988
MAXERECT
K881008 · LKY
Kenneth Chapman
Gastroenterology & Urology · 217d
Cleared Oct 12, 1988
MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
K881259 · LYE
Triton Biosciences, Inc.
Pathology · 203d
Cleared Oct 12, 1988
DIGITRON STENOSIS PROTOCOL
K881481 · LLZ
Siemens Gammasonics, Inc.
Radiology · 187d
Cleared Oct 12, 1988
100-01778-52 ULTRASOUND SYSTEM
K882478 · IYO
Diasonics, Inc.
Radiology · 118d
Cleared Oct 12, 1988
AMBULATORY PH DATA RECORDER SYSTEM, APH-2000
K882551 · KLA
Intl. Biomedics, Inc.
Gastroenterology & Urology · 113d