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
133201–133224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
K884193 · GQS
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
K884194 · GQS
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
TECHNICON RA-PHENOBARBITAL
K884419 · DLZ
Technicon Instruments Corp.
Toxicology · 33d
Cleared Nov 22, 1988
MODIFICATION MIC/API UNISCEPT(R)
K884509 · JWY
Analytical Products, Inc.
Microbiology · 26d
Cleared Nov 22, 1988
MODIFICATION MICRO-MIC
K884510 · JWY
Analytical Products, Inc.
Microbiology · 26d
Cleared Nov 22, 1988
RPMI-1640 HYBRI-MAX, PROD. NO. R5382
K884572 · KIT
Sigma Chemical Co.
Pathology · 21d
Cleared Nov 22, 1988
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891
K884573 · KIT
Sigma Chemical Co.
Pathology · 21d
Cleared Nov 22, 1988
DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785
K884574 · KIT
Sigma Chemical Co.
Pathology · 21d
Cleared Nov 22, 1988
MODIFIED SLIDING RECONSTITUTION DEVICE
K884626 · LHI
Baxter Healthcare Corp
General Hospital · 15d
Cleared Nov 22, 1988
MULTI-PURPOSE HOLDER
K884630 · LDQ
Med-Dex Intl.
General & Plastic Surgery · 15d
Cleared Nov 21, 1988
HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER
K883133 · FOX
Ferguson Medical
General Hospital · 118d
Cleared Nov 21, 1988
WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS
K883186 · DWL
Wright Linear Pump, Inc.
General Hospital · 116d
Cleared Nov 21, 1988
LIFEGUARD VENT MASK
K883383 · CBP
Breath of Life, Inc.
Anesthesiology · 104d
Cleared Nov 21, 1988
SUNDERLAND NASAL TUBE
K883668 · BTQ
Exmoor Plastics , Ltd.
Anesthesiology · 87d
Cleared Nov 21, 1988
DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
K883793 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 75d
Cleared Nov 21, 1988
MODIFIED REFLUX REDUCER
K883818 · FMS
Physician Engineered Products, Inc.
General Hospital · 74d
Cleared Nov 21, 1988
IMAGER
K883831 · IZI
Fischer Imaging Corp.
Radiology · 73d
Cleared Nov 21, 1988
ADVANTAGE
K883860 · IZI
Fischer Imaging Corp.
Radiology · 69d
Cleared Nov 21, 1988
NEOSOFT UMBILICAL VESSEL CATHETER
K883866 · FOZ
Menlo Care, Inc.
General Hospital · 69d
Cleared Nov 21, 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
K883872 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Nov 21, 1988
CARDIAC CX
K883985 · JAA
Fischer Imaging Corp.
Radiology · 62d
Cleared Nov 21, 1988
VISTA MR 2055 HP SYSTEM
K883994 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Nov 21, 1988
PORTABLE OXYGEN GENERATOR
K884084 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 55d
Cleared Nov 21, 1988
MODIFIED CONCHATHERM III CONTROLLED HEATER
K884150 · BTT
Respiratory Care, Inc.
Anesthesiology · 49d