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

Filters: Cleared only ×
175,230 results
148489–148512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1985
ULTRACLONE ECL-01-800 CELL LINE
K851545 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 24d
Cleared May 10, 1985
WI-38 GENCELLS
K851561 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
MRC-5 GENCELLS
K851562 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
RK GENCELLS
K851563 · KIR
Genus Diagnostics
Pathology · 24d
Cleared May 10, 1985
EMIT 700 BENZODIAZEPINE ASSAY
K851568 · JXM
Syva Co.
Toxicology · 24d
Cleared May 10, 1985
THIOGLYCOLLATE WITHOUT INDICATOR
K851598 · JSG
Preferred Micro-Media
Microbiology · 24d
Cleared May 10, 1985
SPIROMED 2
K851620 · BZG
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared May 10, 1985
BOOM ARM
K851621 · BSZ
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared May 10, 1985
DEMAND MAGNESIUM
K851657 · JGJ
Cooper Biomedical, Inc.
Chemistry · 17d
Cleared May 10, 1985
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
K851670 · JIT
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared May 10, 1985
THERMOMED
K851704 · FLL
Draeger Medical, Inc.
General Hospital · 15d
Cleared May 10, 1985
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · KZD
Datascope Corp.
General Hospital · 10d
Cleared May 09, 1985
CATARACT TRAY
K842647 · HNN
Deroyal Industries, Inc.
Ophthalmic · 303d
Cleared May 09, 1985
STERILE EYE SURGERY KITS
K842990 · HOZ
Biological & Environmental Control...
Ophthalmic · 283d
Cleared May 09, 1985
IOCARE CONVERTER KIT
K843276 · HQC
Chiron Vision Corp.
Ophthalmic · 262d
Cleared May 09, 1985
MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL
K844440 · LKW
Cooper Lasersonics, Inc.
Neurology · 174d
Cleared May 09, 1985
PHARMASEAL EYE PREP TRAY
K850119 · HNR
American Pharmaseal Div. Ahsc
Ophthalmic · 115d
Cleared May 09, 1985
HERPES SIMPLEX GROUP CF ANTIGEN
K850609 · GQN
Hillcrest Biologicals
Microbiology · 83d
Cleared May 09, 1985
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
K850793 · JDL
Intermedics Orthopedics
Orthopedic · 72d
Cleared May 09, 1985
SENTINOL -ORTHODONTIC ARCH WIRE
K851055 · DZC
Gac Intl., Inc.
Dental · 56d
Cleared May 09, 1985
INOX DRY HEAT STERILIZER
K851307 · KMH
Broadwest Corp.
General Hospital · 38d
Cleared May 09, 1985
BIGGY AGAR NICKERSONS MEDIUM
K851576 · JSH
Preferred Micro-Media
Microbiology · 23d
Cleared May 09, 1985
SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420
K851883 · HDA
The Huxley Instrument Corp.
Obstetrics & Gynecology · 10d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · JPA
Warner-Lambert Co.
Hematology · 93d