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
96001–96024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1996
VISUALINE D HCG
K963408 · JHI
Sun Biomedical Laboratories, Inc.
Chemistry · 50d
Cleared Oct 18, 1996
MEDLINE ZIPPER SLEEVED VEST
K963452 · FMQ
Medline
General Hospital · 45d
Cleared Oct 18, 1996
PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM...
K963458 · FMQ
Skil-Care Corp.
General Hospital · 45d
Cleared Oct 18, 1996
WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE...
K963569 · FMQ
Medline Industries, Inc.
General Hospital · 43d
Cleared Oct 18, 1996
SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
K963570 · FMJ
Smiths Industries Medical Systems, Inc.
General Hospital · 43d
Cleared Oct 18, 1996
C.O.L.D.A.
K963630 · HQY
C.O.L.D.A. S.N.C.
Ophthalmic · 37d
Cleared Oct 18, 1996
RAND NASAL PACKING
K963856 · EMX
Rand Scientific Corp.
Ear, Nose, Throat · 23d
Cleared Oct 17, 1996
MICROCO
K950197 · CCJ
Micro Direct, Inc.
Anesthesiology · 638d
Cleared Oct 17, 1996
LOG-A-RYTHM MODEL 100 AND MODEL 1001
K952790 · DRT
Nian-Crae, Inc.
Cardiovascular · 486d
Cleared Oct 17, 1996
SPETZLER TI 100 ANEURYSM CLIP
K955064 · HCH
Elekta Instruments, Inc.
Neurology · 346d
Cleared Oct 17, 1996
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · LFZ
Incstar Corp.
Microbiology · 260d
Cleared Oct 17, 1996
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
K960479 · LDF
Arrow Intl., Inc.
Cardiovascular · 258d
Cleared Oct 17, 1996
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
K961499 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 182d
Cleared Oct 17, 1996
OPTICHAMBER
K962822 · CAF
Healthscan Products, Inc.
Anesthesiology · 90d
Cleared Oct 17, 1996
VISTA BRITE TIP CATHETERS
K962830 · DQY
Cordis Corp.
Cardiovascular · 87d
Cleared Oct 17, 1996
S-ROM HIP SYSTEM - LOCKING PLUG
K963206 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 62d
Cleared Oct 17, 1996
PROD. NO. 02-031 - LACERATION TRAY
K963443 · LRO
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 48d
Cleared Oct 16, 1996
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
K960074 · DTZ
Terumo Medical Corp.
Cardiovascular · 279d
Cleared Oct 16, 1996
HF MEGA EAR
K960567 · EPF
Maxi-Aids, Inc.
Ear, Nose, Throat · 250d
Cleared Oct 16, 1996
HANS RUDOLPH NASAL CPAP MASK
K962848 · BYG
Hans Rudolph, Inc.
Anesthesiology · 86d
Cleared Oct 16, 1996
STRAIT JACKET
K963463 · FMQ
Deroyal Industries, Inc.
General Hospital · 43d
Cleared Oct 16, 1996
ELVAREX
K963573 · DWL
Jobst A Beiersdorf Co.
General Hospital · 41d
Cleared Oct 16, 1996
SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
K963769 · MQX
Seirin-America, Inc.
General Hospital · 27d
Cleared Oct 16, 1996
HEMOCUE HEMOLIN
K963908 · GGM
Direct Solutions
Hematology · 16d