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
100393–100416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1995
BOAT NOSE OBTURATOR
K954458 · HRX
Phx Technologies Corp.
Orthopedic · 28d
Cleared Oct 23, 1995
CONICAL OBTURATOR
K954459 · HRX
Phx Technologies Corp.
Orthopedic · 28d
Cleared Oct 23, 1995
DISSECTING OBTURATOR
K954463 · HRX
Phx Technologies Corp.
Orthopedic · 28d
Cleared Oct 23, 1995
CARPAL TUNNEL SLOTTED CANNULA
K954464 · HRX
Phx Technologies Corp.
Orthopedic · 28d
Cleared Oct 23, 1995
BLUNT DISSECTOR, CURVED
K954475 · HRX
Phx Technologies Corp.
Orthopedic · 27d
Cleared Oct 23, 1995
PROBE
K954476 · HRX
Phx Technologies Corp.
Orthopedic · 27d
Cleared Oct 23, 1995
RECLOSABLE WOUND COVER
K954621 · FRO
Hollister, Inc.
General & Plastic Surgery · 18d
Cleared Oct 23, 1995
CONMED ELECTROSURGICAL GROUNDING PAD
K954633 · GEI
Conmedcorp
General & Plastic Surgery · 17d
Cleared Oct 23, 1995
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · FCK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 12d
Cleared Oct 20, 1995
HYS-SURGIMAT
K934866 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 738d
Cleared Oct 20, 1995
ZIRCONIA CERAMIC FEMORAL HEAD
K944689 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 393d
Cleared Oct 20, 1995
IL682, CO-OXIMETER
K945677 · GKR
Instrumentation Laboratory CO
Hematology · 336d
Cleared Oct 20, 1995
PROTEIN C DEFICIENT PLASMA
K945857 · GJT
George King Bio-Medical, Inc.
Hematology · 340d
Cleared Oct 20, 1995
OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES
K946335 · GKZ
Immunotech, Inc.
Hematology · 295d
Cleared Oct 20, 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 224d
Cleared Oct 20, 1995
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 200d
Cleared Oct 20, 1995
THROMBOPLASTIN-LI REAGENT
K951820 · GJS
Helena Laboratories
Hematology · 183d
Cleared Oct 20, 1995
PH-DETECT TEST
K952178 · JQY
Diagnostic Reagents, Inc.
Chemistry · 164d
Cleared Oct 20, 1995
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K953264 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 99d
Cleared Oct 20, 1995
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · GTQ
Olympus America, Inc.
Microbiology · 91d
Cleared Oct 20, 1995
NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
K953472 · DXN
Nellcor, Inc.
Cardiovascular · 88d
Cleared Oct 20, 1995
TRILOGY ACETABULAR SHELL & LINERS 36MM
K953490 · LPH
Zimmer, Inc.
Orthopedic · 87d
Cleared Oct 20, 1995
O.B. APPLICATOR TAMPONS
K953638 · HIL
Personal Products Co.
Obstetrics & Gynecology · 77d
Cleared Oct 20, 1995
BREATHE RIGHT NASAL STRIP
K953772 · LWF
Cns, Inc.
Ear, Nose, Throat · 67d