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
131401–131424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1989
TEMPTEK 5010 THERMAL COOLING BLANKET
K891092 · ILO
Temptek, Inc.
Physical Medicine · 85d
Cleared May 26, 1989
VITRECTOMY PACK #J120
K891161 · HQC
O.R. Specialties, Inc.
Ophthalmic · 81d
Cleared May 26, 1989
LEUCOPREP CELL SEPARATION TUBE
K891407 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 73d
Cleared May 26, 1989
STERILE BURNNET PRE-CUT (VARIOUS SIZES)
K891459 · NAD
Western Medical, Ltd.
General & Plastic Surgery · 72d
Cleared May 26, 1989
LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS
K891909 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 60d
Cleared May 26, 1989
ORTHO-J, INC. BEK-JS-004
K891917 · JEB
Ortho-J, Inc.
General & Plastic Surgery · 60d
Cleared May 26, 1989
MAGNILINK SYSTEM 101
K892347 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 201
K892348 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 209
K892349 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 402/5
K892350 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 602
K892351 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
COMFORTRAC, CT90 & CT100 BI-PHASICS
K892669 · ISA
Comfortrac Systems
Physical Medicine · 43d
Cleared May 26, 1989
ANGIOTEC ZX DIGITAL IMAGE PROCESSOR
K892869 · LLZ
Andros Analyzers, Inc.
Radiology · 37d
Cleared May 26, 1989
PROXIMATE LINEAR CUTTER THICK TISSUE INST.
K892927 · GAG
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared May 26, 1989
MINI-DIAMOND KNIFE
K893033 · GDX
L.A.B. Instruments
General & Plastic Surgery · 32d
Cleared May 26, 1989
SPINALATOR JS-1100 TRACTION UNIT
K893168 · ITH
The Spinalator Co.
Physical Medicine · 42d
Cleared May 26, 1989
ALPHA MALLARD
K893248 · INI
Alpha Unlimited, Inc.
Physical Medicine · 28d
Cleared May 25, 1989
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
K885139 · BTO
Pertrach
Anesthesiology · 161d
Cleared May 25, 1989
OXITRON OXYGEN SENSOR
K890144 · CCL
Oxitron Medical Products
Anesthesiology · 132d
Cleared May 25, 1989
INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES
K891105 · GXY
Acudata Software
Neurology · 84d
Cleared May 25, 1989
INDICATENS INDICATOR ELECTRODE MODEL 2
K891107 · GXY
Acudata Software
Neurology · 84d
Cleared May 25, 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488 · CAW
Invacare Corp.
Anesthesiology · 69d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891661 · LYY
Dmp, Inc.
General Hospital · 66d
Cleared May 25, 1989
LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)
K891728 · LYY
Baldur Systems Corp.
General Hospital · 63d