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
148537–148560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1985
GELIPERM ABSORBIND GRANULATED GEL
K850819 · FRO
Geistlich-Pharma
General & Plastic Surgery · 68d
Cleared May 07, 1985
PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV
K850888 · LJT
Creative Care Systems, Inc.
General Hospital · 64d
Cleared May 07, 1985
SMART ALEX II MULTI-FILTER PHOTOMETER
K850993 · JJQ
Awareness Technology, Inc.
Chemistry · 57d
Cleared May 07, 1985
QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
K851017 · FRN
Quest Medical, Inc.
General Hospital · 56d
Cleared May 07, 1985
CORRECT FLO
K851299 · FPA
Norton Performance Plastics Corp.
General Hospital · 36d
Cleared May 07, 1985
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · CGJ
Amersham Corp.
Chemistry · 33d
Cleared May 07, 1985
SANDARE IRON-BINDING CAPACITY PROCEDURE
K851395 · JMO
Sandare Chemical Co., Inc.
Chemistry · 28d
Cleared May 07, 1985
VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
K851474 · LAZ
Vygon Corp.
Toxicology · 22d
Cleared May 07, 1985
VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K851478 · BSP
Vygon Corp.
Anesthesiology · 22d
Cleared May 07, 1985
VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
K851480 · LAE
Vygon Corp.
Toxicology · 22d
Cleared May 07, 1985
SUNTANNING EQUIPMENT
K851532 · FTC
Oakport Intl., Inc.
General & Plastic Surgery · 21d
Cleared May 07, 1985
ADJUSTABLE TREATMENT TABLES
K851690
I-Rep, Inc.
Physical Medicine · 21d
Cleared May 06, 1985
THE I.V. BAG
K844664 · KPE
Kabivitrum, Inc.
General Hospital · 157d
Cleared May 06, 1985
QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM
K850455 · IZI
Xre Corp.
Radiology · 89d
Cleared May 03, 1985
STERILE DISPOSABLE PN DRAPE SYSTEM
K850912 · KKX
Brant-Wald Surgicals, Inc.
General Hospital · 59d
Cleared May 03, 1985
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared May 03, 1985
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · GBX
Vygon Corp.
General & Plastic Surgery · 18d
Cleared May 03, 1985
VYGON EXCHANGE TRANSFUSION TRAY 275.00
K851477 · BRZ
Vygon Corp.
General Hospital · 18d
Cleared May 03, 1985
CODMAN DISPOSABLE BIPOLAR CARD
K851487 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 18d
Cleared May 03, 1985
DERMA PREP
K851612 · KGT
Mowbray Co., Inc.
General Hospital · 15d
Cleared May 03, 1985
SHOULDER TRACTION KIT
K851656
Chattanooga Group, Inc.
General & Plastic Surgery · 10d
Cleared May 03, 1985
UNIVERSAL COMPUTER INTERFACE SYSTEM
K851706 · BZM
Vacumetrics, Inc.
Anesthesiology · 8d
Cleared May 02, 1985
PATHO DX LATEX AGGLUTINATION STREP B KIT
K845022 · GTZ
Diagnostic Products Corp.
Microbiology · 126d
Cleared May 02, 1985
SYSTEM 8000 CELL COUNTER
K850386 · GKL
Baker Instructions Corp.
Hematology · 90d