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

Filters: Cleared only ×
176,076 results
152425–152448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1984
ACU220 CRYO UNIT
K841294 · HQA
Keller Instruments, Inc.
Ophthalmic · 139d
Cleared Aug 15, 1984
QUAZAR ESOPHAGEAL STETHOSCOPE
K841574 · BZW
Axiom Medical, Inc.
Anesthesiology · 120d
Cleared Aug 15, 1984
SIDE CUTTING SERRATED BLADE
K841980 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 93d
Cleared Aug 15, 1984
ACU-DERM TRANSPARENT IV DRESSING
K842064 · KMK
Acme United Corp.
General & Plastic Surgery · 86d
Cleared Aug 15, 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · KQO
Miles Laboratories, Inc.
Chemistry · 71d
Cleared Aug 15, 1984
ACTH NORMAL RANGE
K842249 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 70d
Cleared Aug 15, 1984
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE
K842250 · HQF
American Medical Optics
Ophthalmic · 77d
Cleared Aug 15, 1984
AMERI. MEDICAL OPTICS ARGON LASER PHOTO
K842251 · HQF
American Medical Optics
Ophthalmic · 77d
Cleared Aug 15, 1984
TDX REA CHOLESTEROL
K842320 · CHH
Abbott Laboratories
Chemistry · 64d
Cleared Aug 15, 1984
ACA BARBITURATES SCREEN/BENZODIAZEPIN
K842386 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 58d
Cleared Aug 15, 1984
ACA BENZODIAZEPINES SCREEN TEST PK
K842387 · JXM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 58d
Cleared Aug 15, 1984
DR. GOULD HAND PACK SUSTOM STERIL
K842405 · FRG
Pro-Lab, Inc.
General Hospital · 57d
Cleared Aug 15, 1984
WAKO LDH CII TEST
K842452 · CFH
Wako Chemicals USA, Inc.
Chemistry · 54d
Cleared Aug 15, 1984
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · HQC
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Aug 15, 1984
SITE GILLS STYLE I/A HANDPIECE
K842459
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Aug 15, 1984
PORTABLE ACUIOMETER
K842567 · HLJ
Randwal Instrument Co., Inc.
Ophthalmic · 44d
Cleared Aug 15, 1984
GAUZE & LAB SPONGES STERILE & NON
K842572 · GDY
Ulti-Med Intl., Inc.
General & Plastic Surgery · 43d
Cleared Aug 15, 1984
GILL HEMATOXYLIN STAIN
K842741 · HYJ
E K Ind., Inc.
Pathology · 33d
Cleared Aug 15, 1984
GIEMSA STAIN
K842742 · HYF
E K Ind., Inc.
Hematology · 33d
Cleared Aug 15, 1984
OXYGEN CONCENTRATOR
K842753 · CAW
Bv Medical Equipment Co.
Anesthesiology · 30d
Cleared Aug 15, 1984
SUNBED
K842787 · FTC
Sun Health Systems
General & Plastic Surgery · 27d
Cleared Aug 15, 1984
STREPTEX ZL01
K842828 · JTO
Wellcome Diagnostics
Immunology · 26d
Cleared Aug 15, 1984
ESOPHAGEAL STETHOSCOPE
K842865 · BZW
Inmed Corp.
Anesthesiology · 23d
Cleared Aug 15, 1984
THE SUTURER
K842912
Vlm Surgical, Inc.
General & Plastic Surgery · 21d