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
136105–136128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1988
MARQUETTE MEDICAL, INC. IV EXTENSION SETS
K880928 · FPA
Marquette Medical, Inc.
General Hospital · 56d
Cleared Apr 29, 1988
NDYAG LASER TRACHEAL TUBE
K880960 · BTR
Sheridan Catheter Corp.
Anesthesiology · 52d
Cleared Apr 29, 1988
ALCON SURGICAL PROCEDURE PACKS
K880961 · LRO
Alcon Laboratories
General & Plastic Surgery · 52d
Cleared Apr 29, 1988
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K881117 · JDI
Richards Medical Co., Inc.
Orthopedic · 51d
Cleared Apr 29, 1988
NEEDLE SHIELD NEEDLE DISPOSAL UNIT
K881390 · FPA
Xenetics Biomedical, Inc.
General Hospital · 25d
Cleared Apr 29, 1988
OPERATING ROOM TOWELS -STERILE & NON-STERILE
K881396 · KKX
A Plus International, Inc.
General Hospital · 25d
Cleared Apr 29, 1988
TOURNIQUET
K881398 · GAX
Barretta Products, Research and...
General & Plastic Surgery · 25d
Cleared Apr 29, 1988
OPHTHALMIC CANNULA
K881487 · HMX
Surgical Instrument, Inc.
Ophthalmic · 21d
Cleared Apr 29, 1988
SURGILASE YAG 100 FOR GYNECOLOGY USE
K881499 · LLO
Surgilase, Inc.
Anesthesiology · 38d
Cleared Apr 29, 1988
COMPRESAID
K881516 · FZF
R. Evans Corp.
General & Plastic Surgery · 18d
Cleared Apr 29, 1988
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · BYE
Ohmeda Medical
Anesthesiology · 17d
Cleared Apr 28, 1988
GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
K873577 · CHL
Diamond Sensor Systems
Chemistry · 238d
Cleared Apr 28, 1988
ACS HI-TORQUE GUIDE WIRES
K874202 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 196d
Cleared Apr 28, 1988
MICRO-BUMINTEST REAGENT TABLETS
K874909 · JIR
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Apr 28, 1988
CHOLESTEROL
K880237 · CHH
Tech-Neal Scientific, Inc.
Chemistry · 99d
Cleared Apr 28, 1988
DESCENDING ARCH CANNULA
K880421 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Apr 28, 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 86d
Cleared Apr 28, 1988
PREGNANCY BETA-HCG CARD & LIQUID TEST
K880478 · JHJ
Ampcor, Inc.
Chemistry · 84d
Cleared Apr 28, 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · DXT
Medrad, Inc.
Cardiovascular · 83d
Cleared Apr 28, 1988
VACUGUARD(TM)
K880594 · JKA
Habley Medical Technology Corp.
Chemistry · 77d
Cleared Apr 28, 1988
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 58d
Cleared Apr 28, 1988
MICRO CO2 APPARATUS
K880967 · CIE
Hf Scientific, Inc.
Chemistry · 51d
Cleared Apr 28, 1988
PARAMAX IRON REAGENT
K881104 · JIY
Baxter Healthcare Corp
Chemistry · 44d
Cleared Apr 28, 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · CGJ
Nichols Institute Diagnostics
Chemistry · 43d