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
162457–162480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1981
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · FKO
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 24d
Cleared Dec 18, 1981
DIRECT FA CONJUGATE FOR LEGIONELLA SP
K813339 · LHL
Springwood Microbiologicals
Microbiology · 24d
Cleared Dec 18, 1981
WOUND-EVAC
K813341 · GCY
Heritage Medical Products
General & Plastic Surgery · 23d
Cleared Dec 18, 1981
TOBRAMYCIN REAGENT TEST KIT
K813391 · LKB
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Dec 18, 1981
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
K813409 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 14d
Cleared Dec 18, 1981
DOCUMENT LINEARITY TEST STANDARDS
K813411 · JIX
North American Standards
Chemistry · 14d
Cleared Dec 18, 1981
NON-ADHER PADS
K813421 · KGX
Abco Dealers, Inc.
General & Plastic Surgery · 11d
Cleared Dec 18, 1981
THERMOMETER SHEATHS
K813423 · FLK
Abco Dealers, Inc.
General Hospital · 11d
Cleared Dec 18, 1981
THERMOMETERS
K813424 · FLK
Abco Dealers, Inc.
General Hospital · 11d
Cleared Dec 18, 1981
BAXA ADLI SEAL
K813435 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 10d
Cleared Dec 18, 1981
PHILLY BOLT
K813440 · GWM
Philadelphia Medical Specialties
Neurology · 10d
Cleared Dec 17, 1981
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
K812298 · GHH
Syn-Kit, Inc.
Immunology · 125d
Cleared Dec 17, 1981
PCS-5 ACCESSORIES
K812766 · BTI
Timeter Instrument Corp.
Anesthesiology · 73d
Cleared Dec 17, 1981
A-1 TEST
K812788 · JHJ
C.F. Medical, Inc.
Toxicology · 73d
Cleared Dec 17, 1981
ACU-SLIDE TEST
K812789 · JHJ
C.F. Medical, Inc.
Microbiology · 73d
Cleared Dec 17, 1981
ASTRA REAGENT CONCENTRATE SYSTEM
K812866 · CGA
Nobel Scientific Industries, Inc.
Chemistry · 65d
Cleared Dec 17, 1981
QAC CONTROL
K812950 · DIF
The Quality Assurance Service Corp.
Toxicology · 57d
Cleared Dec 17, 1981
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK
K812994 · JTN
General Diagnostics
Microbiology · 52d
Cleared Dec 17, 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · JTO
Abbott Laboratories
Microbiology · 50d
Cleared Dec 17, 1981
ANDRIA-FSH RIA TEST KIT
K813086 · CGJ
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 17, 1981
ABURIA-CK RIA TEST KIT
K813087 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 17, 1981
SECURE FDI TEST KIT
K813216 · JHG
Beckman Instruments, Inc.
Chemistry · 38d
Cleared Dec 17, 1981
CARAFLEX ELASTIC POLYMER PLASTER BANDA
K813219 · ITG
Carapace, Inc.
Physical Medicine · 38d
Cleared Dec 17, 1981
RIAGEN PAP RIA
K813261 · JFH
Biogenex Laboratories
Chemistry · 27d