Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80377–80400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 27, 2001
WILLI GELLER CREAPEARL
K010160 · ELM
Jensen Industries, Inc.
Dental · 70d
Cleared Mar 27, 2001
CALEX CONDITIONER
K010176 · EJK
Stephen M Koral, Dmd
Dental · 68d
Cleared Mar 27, 2001
POLYCARBOXYLATE (PCA) CEMENT
K010240 · EMA
Rite-Dent Manufacturing Corp.
Dental · 61d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
K010347 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDER FREE
K010356 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
R & D DESIGNATION AP-035
K010414 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · KNS
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · ODC
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 27, 2001
R & D DESIGNATION AP-047
K010611 · EJT
Jensen Industries, Inc.
Dental · 26d
Cleared Mar 26, 2001
PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE
K000655 · IRP
Ahava Stein
Physical Medicine · 392d
Cleared Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
K001734 · MGZ
Edwards Lifesciences, LLC
Cardiovascular · 292d
Cleared Mar 26, 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · MBI
Dj Orthopedics, LLC
Orthopedic · 196d
Cleared Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · LPN
Ciba Vision Corporation
Ophthalmic · 152d
Cleared Mar 26, 2001
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
K003993 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
K004006 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K010013 · GEI
Valleylab, Inc.
General & Plastic Surgery · 83d
Cleared Mar 26, 2001
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)
K010088 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
K010089 · GWQ
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K010090 · GWF
Excel Tech. , Ltd.
Neurology · 74d
Cleared Mar 26, 2001
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC)...
K010256 · LPL
Opti-Centre Laboratories
Ophthalmic · 56d
Cleared Mar 26, 2001
AMS FASCIAL-ANCHORING SYSTEM
K010277 · NEH
American Medical Systems, Inc.
General & Plastic Surgery · 55d
Cleared Mar 26, 2001
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700,...
K010403 · NBW
Home Diagnostics, Inc.
Chemistry · 42d
Cleared Mar 23, 2001
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
K000977 · DTR
Olson Medical Sales, Inc.
Cardiovascular · 361d