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
133177–133200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1989
STRABISMUS SCISSORS
K890264 · LRW
Kinetic Medical Products
General & Plastic Surgery · 9d
Cleared Jan 26, 1989
ANGIOSCOPE FOR PULMONARY ARTERY USE
K882658 · DQO
Washington Regulatory Services
Cardiovascular · 211d
Cleared Jan 26, 1989
OPTIMA MPT AND SPT PACEMAKERS
K884411 · DXY
Telectronics, Inc.
Cardiovascular · 98d
Cleared Jan 26, 1989
EURO-COLLINS SOLUTION SETS
K884609 · KDL
Fresenius USA, Inc.
Gastroenterology & Urology · 80d
Cleared Jan 26, 1989
NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
K885149 · DWO
Hart Enterprises, Inc.
General & Plastic Surgery · 42d
Cleared Jan 26, 1989
SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)
K890174 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Jan 25, 1989
RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER
K882975 · FMF
Richmann Laboratories
General Hospital · 194d
Cleared Jan 25, 1989
UNILITH 3 MODELS 7580/7583/7680/7683
K883037 · DXY
Ela Medical, Inc.
Cardiovascular · 190d
Cleared Jan 25, 1989
DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A
K883359 · IYO
Toshiba Medical Systems
Radiology · 168d
Cleared Jan 25, 1989
MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH
K883454 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 163d
Cleared Jan 25, 1989
BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
K885019 · FRG
Bemis Health Care
General Hospital · 57d
Cleared Jan 25, 1989
SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
K885235 · DSK
Spectramed, Inc.
Cardiovascular · 36d
Cleared Jan 25, 1989
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K885262 · DRX
Valleylab, Inc.
Cardiovascular · 33d
Cleared Jan 25, 1989
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · DRS
Baxter Healthcare Corp
Cardiovascular · 29d
Cleared Jan 24, 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344 · DIC
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 300d
Cleared Jan 24, 1989
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K882517 · HLI
Rodenstock Instrument Corp.
Ophthalmic · 221d
Cleared Jan 24, 1989
SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
K882826 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 200d
Cleared Jan 24, 1989
MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2
K883379 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 167d
Cleared Jan 24, 1989
TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
K883720 · LGD
Lmd Laboratories
Microbiology · 146d
Cleared Jan 24, 1989
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 131d
Cleared Jan 24, 1989
ROTACUBE
K884017 · LIQ
Difco Laboratories, Inc.
Microbiology · 124d
Cleared Jan 24, 1989
LUNDY VAPORIZER SYSTEM
K884090 · CAD
Vaporflow Technology, Inc.
Anesthesiology · 118d
Cleared Jan 24, 1989
DU PONT ANALYST THYROID ROTOR
K884169 · CEL
The DU Pont Co.
Chemistry · 112d
Cleared Jan 24, 1989
SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL
K884182 · GEX
Surgilase, Inc.
General & Plastic Surgery · 118d