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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

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175,230 results
161617–161640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 17, 1981
A-1 IN-HOME PREGNANCY TEST
K813272 · LCX
C.F. Medical, Inc.
Chemistry · 27d
Cleared Dec 17, 1981
NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
K813288 · DDG
New England Immunology Assoc.
Immunology · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
K813293 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
K813294 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
K813295 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
RA-80 POSITIVE CONTROL
K813309 · DHR
Sun-Kit
Immunology · 23d