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
124105–124128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1990
GEN-PROBE PAL LUMINOMETER
K903911 · JJQ
Gen-Probe, Inc.
Chemistry · 41d
Cleared Oct 04, 1990
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
K903933 · JJY
Baxter Healthcare Corp
Chemistry · 38d
Cleared Oct 04, 1990
ELECTRO-BLEND EPILATOR, MODEL UC-3
K904015 · KCW
A.R. Hinkel Co., Inc.
General & Plastic Surgery · 34d
Cleared Oct 04, 1990
INSYTE-A ARTERIAL CATHETERIZATION UNIT
K904122 · FOZ
Deseret Medical, Inc.
General Hospital · 28d
Cleared Oct 04, 1990
OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.
K904337 · BYX
Medical Fittings, Inc.
Anesthesiology · 14d
Cleared Oct 03, 1990
MOORE TYPE ENDO PROSTHESIS
K900051 · KWY
Lima Intl. Corp.
Orthopedic · 273d
Cleared Oct 03, 1990
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
K900858 · GEX
Candela Laser Corp.
General & Plastic Surgery · 222d
Cleared Oct 03, 1990
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · FNM
Kinetic Concepts, Inc.
General Hospital · 159d
Cleared Oct 03, 1990
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K902939 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 92d
Cleared Oct 03, 1990
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
K902940 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 92d
Cleared Oct 03, 1990
RSI FEMORAL GUIDING CATHETER
K902943 · DQO
Retroperfusion Systems, Inc.
Cardiovascular · 90d
Cleared Oct 03, 1990
DIMENSION-II TOTAL HIP SYSTEM
K902961 · JDI
Kirschner Medical Corp.
Orthopedic · 90d
Cleared Oct 03, 1990
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · GTY
Hybritech, Inc.
Microbiology · 86d
Cleared Oct 03, 1990
MODULAR CATHCART FRACTURE SYSTEM
K903084 · LZY
Depuy, Inc.
Orthopedic · 83d
Cleared Oct 03, 1990
AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE
K903694 · IYT
Amici, Inc.
Radiology · 49d
Cleared Oct 03, 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732 · FOZ
Kendall Healthcare Products Co....
General Hospital · 48d
Cleared Oct 03, 1990
PROTECTED NEEDLE WITH OR WITHOUT IV SET
K903809 · FPA
Kendall Mcgaw Laboratories, Inc.
General Hospital · 44d
Cleared Oct 03, 1990
IVAC(R) SYRINGE PUMP - MODEL 740
K903879 · FRN
Y
General Hospital · 42d
Cleared Oct 03, 1990
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914 · JGQ
Baxter Healthcare Corp
Chemistry · 40d
Cleared Oct 03, 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
K903942 · IZO
Shimadzu Medical Systems
Radiology · 37d
Cleared Oct 03, 1990
MODEL #527 OPHTHALMIC STRETCHER
K904011 · FPO
Midmark Corp.
General Hospital · 35d
Cleared Oct 03, 1990
POLYVIOLENE(TM) SUTURE
K904054 · GAS
Look, Inc.
General & Plastic Surgery · 64d
Cleared Oct 03, 1990
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 27d
Cleared Oct 03, 1990
PRO-LOK (TM) EXTENSION SETS
K904217 · FPA
Vlv Associates, Inc.
General Hospital · 21d