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
127801–127824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1990
BONEFIT R SCREW IMPLANTS
K894595 · DZE
Institut Straumann AG
Dental · 204d
Cleared Feb 13, 1990
MEDICARE GLOVES
K895021 · LYY
Shangrila Latex Industries Pvt. , Ltd.
General Hospital · 189d
Cleared Feb 13, 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · DSH
Del Mar Avionics
Cardiovascular · 138d
Cleared Feb 13, 1990
LATEX PATIENT EXAMINATION GLOVE
K895902 · LYY
Rfb Latex Pvt. , Ltd.
General Hospital · 130d
Cleared Feb 13, 1990
ERBOTOM ACC 450
K896055 · GEI
Erbe Electromedizin GmbH
General & Plastic Surgery · 118d
Cleared Feb 13, 1990
MERCY HIP/KNEE PACK
K896215 · KKX
Westmark, Sterile Packing Systems,...
General Hospital · 110d
Cleared Feb 13, 1990
CO2 REAGENT (340 NM)
K896258 · KHS
Sigma Chemical Co.
Chemistry · 106d
Cleared Feb 13, 1990
BIOPSY PUNCH
K896303 · LRY
Premier Medical
General & Plastic Surgery · 106d
Cleared Feb 13, 1990
EOS IONIZED CALCIUM TEST CARD
K896316 · JFP
Eos Technology Corp.
Chemistry · 104d
Cleared Feb 13, 1990
NON-STERILE LATEX EXAMINATION GLOVES
K896363 · LYY
Contemporary Medical Technology, Inc.
General Hospital · 99d
Cleared Feb 13, 1990
LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2
K896515 · DPW
Tsi, Inc.
Cardiovascular · 90d
Cleared Feb 13, 1990
BISTAT ELECTROSURGICAL UNIT 60-5400-001
K896838 · GEX
Aspen Laboratories, Inc.
General & Plastic Surgery · 70d
Cleared Feb 13, 1990
DIGOXIN-EIA-XT
K896863 · KXT
In Vitro Diagnostics, Inc.
Toxicology · 69d
Cleared Feb 13, 1990
LUTEINIZING HORMONE-EIA-XT
K896866 · CEP
In Vitro Diagnostics, Inc.
Chemistry · 69d
Cleared Feb 13, 1990
ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)
K896997 · FZP
S.P.K. Technology, Inc.
General & Plastic Surgery · 63d
Cleared Feb 13, 1990
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.)
K897040 · GEX
Luxar Corp.
General & Plastic Surgery · 57d
Cleared Feb 13, 1990
PROBE PATIENT EXAMINATION GLOVES
K897187 · LYY
Glove India Pvt. , Ltd.
General Hospital · 47d
Cleared Feb 13, 1990
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033 · GEY
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 42d
Cleared Feb 13, 1990
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
K900332 · GEI
3M Company
General & Plastic Surgery · 21d
Cleared Feb 13, 1990
COLORVISION SUNGLASSES
K900381 · HQY
Blublocker Corp.
Ophthalmic · 19d
Cleared Feb 13, 1990
BLUBLOCKER SUNGLASSES
K900382 · HQY
Blublocker Corp.
Ophthalmic · 19d
Cleared Feb 13, 1990
BULLET SUNGLASSES
K900383 · HQY
Blublocker Corp.
Ophthalmic · 19d
Cleared Feb 13, 1990
MODIFIED SINGLE USE LATEX EXAMINATION GLOVES
K900453 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 14d
Cleared Feb 13, 1990
MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES
K900454 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 14d