FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124681–124704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1990
LOW VOLUME BIFURCATED IV EXTENSION SET
K901088 · FPA
Marquette Medical, Inc.
General Hospital · 211d
Cleared Oct 04, 1990
LOW VOLUME TRIFURCATED IV EXTENSION SET
K901089 · FPA
Marquette Medical, Inc.
General Hospital · 211d
Cleared Oct 04, 1990
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
K901234 · KTT
Kirschner Medical Corp.
Orthopedic · 204d
Cleared Oct 04, 1990
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · FRN
Y
General Hospital · 184d
Cleared Oct 04, 1990
SUDORMED SWEAT PATCH SPECIMEN CONTAINER
K902442 · JKA
Sudormed, Inc.
Chemistry · 125d
Cleared Oct 04, 1990
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · JIW
Diagnostic Products Corp.
Chemistry · 115d
Cleared Oct 04, 1990
FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)
K902972 · EBI
Cmp Industries, LLC
Dental · 90d
Cleared Oct 04, 1990
ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)
K903079 · GEX
Luxar Corp.
General & Plastic Surgery · 84d
Cleared Oct 04, 1990
SYNERMED CALCIUM REAGENT KIT
K903233 · CIC
Synermed, Inc.
Chemistry · 73d
Cleared Oct 04, 1990
STERILE URETHRAL CATHETER PROCEDURE KITS
K903340 · FCM
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 04, 1990
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
K903409 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Oct 04, 1990
LISS CRANIAL STIMULATOR MODEL SBL202-B
K903654 · QJQ
Medical Consultants Intl. , Ltd.
Neurology · 90d
Cleared Oct 04, 1990
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY
K903665 · GKZ
Unipath , Ltd.
Hematology · 50d
Cleared Oct 04, 1990
CREATINE PHOSPHOKINASE
K903775 · CGS
Amresco, Inc.
Chemistry · 45d
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