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
135505–135528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1988
TECH-CAL(TM)/MULTIPLE
K881161 · KSA
R&D Systems, Inc.
Hematology · 45d
Cleared May 02, 1988
VERIFY(R) REFERENCE PLASMA
K881348 · GGN
Organon Teknika Corp.
Hematology · 33d
Cleared Apr 29, 1988
EXL-22DP X-RAY RADIATION THERAPY SYSTEM
K873398 · IYE
Mitsubishi Intl. Corp.
Radiology · 249d
Cleared Apr 29, 1988
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
K874154 · KNT
Electro-Catheter Corp.
Gastroenterology & Urology · 199d
Cleared Apr 29, 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
K875266 · DPT
Toshiba Medical Systems
Cardiovascular · 129d
Cleared Apr 29, 1988
MODEL 210A INFUSION PUMP
K875347 · FRN
Avi, Inc.
General Hospital · 120d
Cleared Apr 29, 1988
MODEL 400A INFUSION PUMP
K875348 · FRN
Avi, Inc.
General Hospital · 120d
Cleared Apr 29, 1988
MODEL 200A INFUSION PUMP
K875365 · FRN
Avi, Inc.
General Hospital · 120d
Cleared Apr 29, 1988
MINI-FILTER, VIROBAC II
K880681 · CAH
King Systems Corp.
General Hospital · 70d
Cleared Apr 29, 1988
BASSINET STAND WITH DRESSING TRAY
K880838 · FMS
Serv-Queen, Inc.
General Hospital · 59d
Cleared Apr 29, 1988
MARQUETTE MEDICAL, INC. IV EXTENSION SETS
K880928 · FPA
Marquette Medical, Inc.
General Hospital · 56d
Cleared Apr 29, 1988
NDYAG LASER TRACHEAL TUBE
K880960 · BTR
Sheridan Catheter Corp.
Anesthesiology · 52d
Cleared Apr 29, 1988
ALCON SURGICAL PROCEDURE PACKS
K880961 · LRO
Alcon Laboratories
General & Plastic Surgery · 52d
Cleared Apr 29, 1988
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K881117 · JDI
Richards Medical Co., Inc.
Orthopedic · 51d
Cleared Apr 29, 1988
NEEDLE SHIELD NEEDLE DISPOSAL UNIT
K881390 · FPA
Xenetics Biomedical, Inc.
General Hospital · 25d
Cleared Apr 29, 1988
OPERATING ROOM TOWELS -STERILE & NON-STERILE
K881396 · KKX
A Plus International, Inc.
General Hospital · 25d
Cleared Apr 29, 1988
TOURNIQUET
K881398 · GAX
Barretta Products, Research and...
General & Plastic Surgery · 25d
Cleared Apr 29, 1988
OPHTHALMIC CANNULA
K881487 · HMX
Surgical Instrument, Inc.
Ophthalmic · 21d
Cleared Apr 29, 1988
SURGILASE YAG 100 FOR GYNECOLOGY USE
K881499 · LLO
Surgilase, Inc.
Anesthesiology · 38d
Cleared Apr 29, 1988
COMPRESAID
K881516 · FZF
R. Evans Corp.
General & Plastic Surgery · 18d
Cleared Apr 29, 1988
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · BYE
Ohmeda Medical
Anesthesiology · 17d
Cleared Apr 28, 1988
GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
K873577 · CHL
Diamond Sensor Systems
Chemistry · 238d
Cleared Apr 28, 1988
ACS HI-TORQUE GUIDE WIRES
K874202 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 196d
Cleared Apr 28, 1988
MICRO-BUMINTEST REAGENT TABLETS
K874909 · JIR
Miles Laboratories, Inc.
Chemistry · 149d