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
152569–152592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1984
WUNDERFIL
K841667 · EBF
Harry J. Bosworth Co.
Dental · 29d
Cleared May 22, 1984
DISPOSABLE POLY GLOVES
K841676 · LZA
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 22, 1984
INNOFLUOR PHENYTOIN
K841706 · LGR
Innotron Diagnostics
Chemistry · 29d
Cleared May 22, 1984
SUNGLASSES
K841794 · HQY
Whole Sale Importers
Ophthalmic · 20d
Cleared May 22, 1984
CODE-A-WELL SERIES 300 PLATE
K841937 · LIB
Plastic Injectors, Inc.
Microbiology · 11d
Cleared May 21, 1984
CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
K833447 · MCB
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 229d
Cleared May 21, 1984
BLOOD PRESSURE MONITOR BP600X
K834441 · DXN
Lifeline Systems, Inc.
Cardiovascular · 157d
Cleared May 21, 1984
KERR RESIN BONDED BRIDGE CEMENT
K840407 · EMA
Sybron Corp.
Dental · 111d
Cleared May 21, 1984
TYCOS SELF CHECK BPM3 BLOOD PRESS MONI
K840469 · DXN
Sybron Corp.
Cardiovascular · 108d
Cleared May 21, 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · DGC
Pharmacia, Inc.
Chemistry · 108d
Cleared May 21, 1984
EAR KNIVES
K840764 · JYO
Sharpoint, Inc.
Ear, Nose, Throat · 88d
Cleared May 21, 1984
GRAMS ASPIRATOR S-300
K840803 · BTA
Grams Medical, Inc.
General & Plastic Surgery · 87d
Cleared May 21, 1984
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830 · DER
Ventrex Laboratories, Inc.
Immunology · 87d
Cleared May 21, 1984
TOXO-G EIA DIAGNOSTIC KIT
K840879 · LGD
Abbott Laboratories
Microbiology · 84d
Cleared May 21, 1984
SODIUM CHLORIDE SOLUTION BLOOD CELL
K841183 · FNW
Reagent Laboratory, Inc.
Hematology · 62d
Cleared May 21, 1984
PLASTIC, STERILE TUBING CLOSED SET
K841185 · FPA
Marbex, Inc.
General Hospital · 62d
Cleared May 21, 1984
INFUSION SET SCALP VEIN
K841186 · FPA
Marbex, Inc.
General Hospital · 62d
Cleared May 21, 1984
RUBELLA IGG ANTIBODY ELISA TEST SYS
K841200 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 61d
Cleared May 21, 1984
ALBINAR ELECTRONIC DIGITAL THERMOMETER
K841260 · FLL
Dimension Specialty Co., Inc.
General Hospital · 56d
Cleared May 21, 1984
SOLOPAK BRAND FILTER NEEDLE W/5 MICRO
K841280 · FPB
Smith & Nephew, Mpl Division
General Hospital · 54d
Cleared May 21, 1984
SYRINGE ADDITIVE IV ADMIN. SETS
K841361 · FPA
Quest Medical, Inc.
General Hospital · 49d
Cleared May 21, 1984
AB MANUAL VENTILATION ACCESS. 900C
K841393 · CBK
Siemens Elema AB
Anesthesiology · 48d
Cleared May 21, 1984
VENTREXYME EIA CONTROLS IMMUNOASSAY
K841456 · JIX
Vxr, Inc.
Immunology · 42d
Cleared May 21, 1984
WINDSOR MEDICAL MODEL 50-00002
K841481 · FRN
Windsor Medical, Inc.
General Hospital · 42d