FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
95233–95256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1996
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · LGD
Incstar Corp.
Microbiology · 117d
Cleared Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
K963539 · JJE
Sigma Diagnostics, Inc.
Chemistry · 103d
Cleared Dec 16, 1996
VENTNET
K963633 · MOD
Puritan Bennett Corp.
Anesthesiology · 96d
Cleared Dec 16, 1996
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH...
K963747 · JET
Whitehill Manufacturing, Inc.
Dental · 90d
Cleared Dec 16, 1996
SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350
K963884 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 81d
Cleared Dec 16, 1996
HEART NEBULIZER #100609
K963910 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 77d
Cleared Dec 16, 1996
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS:...
K963934 · MMI
Bio-Rad Laboratories, Inc.
Chemistry · 76d
Cleared Dec 16, 1996
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · JDW
Depuy, Inc.
Orthopedic · 74d
Cleared Dec 16, 1996
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · MNH
Acromed Corp.
Orthopedic · 70d
Cleared Dec 16, 1996
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE...
K964100 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 66d
Cleared Dec 16, 1996
LITHOVAC SUCTION/ASPIRATION PROBE
K964111 · KQT
Electro Medical Systems SA
Gastroenterology & Urology · 62d
Cleared Dec 16, 1996
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL
K964323 · ELW
Fen Dental Mfg., Inc.
Dental · 47d
Cleared Dec 16, 1996
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
K964345 · GAM
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared Dec 16, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH...
K964558 · JLW
Johnson & Johnson Clinical...
Chemistry · 33d
Cleared Dec 16, 1996
N LATEX CRP MONO REAGENT
K964687 · DCH
Behring Diagnostics, Inc.
Immunology · 90d
Cleared Dec 16, 1996
ELECSYS FSH ASSAY
K964693 · CGJ
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Dec 16, 1996
SOLDER GPY
K964705 · EJS
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 16, 1996
SOLDER 650
K964706 · EJS
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 16, 1996
SOLDER 585
K964707 · EJS
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 16, 1996
SOLDER 615
K964708 · EJT
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 16, 1996
SOLDER GPW
K964713 · EJS
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 16, 1996
ELECSYS CALCHECK FSH
K964829 · JIX
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Dec 16, 1996
ELECSYS CALCHECK LH
K964830 · JJX
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Dec 16, 1996
COVERAGE SPRAY HBV
K964835 · LRJ
Convatec, A Division of E.R. Squibb &...
General Hospital · 21d