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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
144913–144936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1986
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
K860895 · JTN
Organon Teknika Corp.
Microbiology · 32d
Cleared Apr 11, 1986
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS
K860919 · DIF
Fisher Scientific Co., LLC
Toxicology · 31d
Cleared Apr 11, 1986
EXEL DENTAL NEEDLE
K861150 · DZM
Exel Intl.
Dental · 16d
Cleared Apr 11, 1986
FORMALDEHYDE SOLUTION, 37%
K861201 · IGG
Surgipath Medical Industries, Inc.
Pathology · 11d
Cleared Apr 11, 1986
ORTHOSOURCE ETCH SYSTEMS
K861245 · EBC
Ortho Source
Dental · 9d
Cleared Apr 11, 1986
TISSUE CULTURE FLASK PL 732 PLASTIC
K861253 · KJA
Travenol Laboratories, S.A.
Pathology · 8d
Cleared Apr 11, 1986
MACCONKEY W/MUG
K861259 · JTO
Remel Co.
Microbiology · 8d
Cleared Apr 11, 1986
BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
K861270 · KEO
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Apr 11, 1986
GAS SAMPLING KIT
K861286 · BZO
Respiratory Support Products, Inc.
Anesthesiology · 4d
Cleared Apr 11, 1986
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
K861330 · CAP
Sechrist Industries, Inc.
Anesthesiology · 2d
Cleared Apr 10, 1986
THRUST-AIRE MODEL 2001
K860618
Charron Industries, Inc.
Physical Medicine · 50d
Cleared Apr 10, 1986
BARD ABSORPTION DRESSING
K861024 · FRO
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Apr 09, 1986
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
K853663 · LPZ
Travenol Laboratories, S.A.
General Hospital · 218d
Cleared Apr 09, 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358 · KHE
Self Care Systems, Inc.
Chemistry · 162d
Cleared Apr 09, 1986
LONG TERM RECORDER RAG 1200
K854866 · DSF
Nihon Kohden America, Inc.
Cardiovascular · 152d
Cleared Apr 09, 1986
NUTRIMIX EMPTY CONTAINER
K860042 · KPE
Abbott Laboratories
General Hospital · 93d
Cleared Apr 09, 1986
MEDCO-SONIC NQ-2000
K860099 · IMI
Medco Products, Co., Inc.
Physical Medicine · 89d
Cleared Apr 09, 1986
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
K860157 · FPA
Quest Medical, Inc.
General Hospital · 83d
Cleared Apr 09, 1986
MODEL 900 INFUSION PUMP
K860229 · FRN
C.R. Bard, Inc.
General Hospital · 77d
Cleared Apr 09, 1986
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
K860640 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Apr 09, 1986
IV FILTER EXTENSION SET
K860803 · FPB
Med Fusion Systems, Inc.
General Hospital · 36d
Cleared Apr 09, 1986
INSPIRON DOUBLE SWIVEL TRACH ADAPTER
K860838 · BZA
Inspiron Corp.
Anesthesiology · 35d
Cleared Apr 09, 1986
KONTRON CUTANEOUS PO2 MONITOR 820
K860951 · KLK
Kontron Instruments, Inc.
Anesthesiology · 28d
Cleared Apr 09, 1986
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
K860961 · LKB
H & P Industries, Inc.
General Hospital · 27d